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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04499924
Registration number
NCT04499924
Ethics application status
Date submitted
31/07/2020
Date registered
5/08/2020
Date last updated
25/03/2025
Titles & IDs
Public title
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
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Secondary ID [1]
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C4251004
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Secondary ID [2]
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SGNTUC-022
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Universal Trial Number (UTN)
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Trial acronym
MOUNTAINEER-02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Adenocarcinoma
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Gastroesophageal Junction Adenocarcinoma
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Esophageal Adenocarcinoma
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Condition category
Condition code
Cancer
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Oesophageal (gullet)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tucatinib
Treatment: Drugs - trastuzumab
Treatment: Drugs - ramucirumab
Treatment: Drugs - paclitaxel
Other interventions - tucatinib placebo
Other interventions - trastuzumab placebo
Experimental: Phase 2 Arm - Tucatinib + trastuzumab + ramucirumab + paclitaxel
Experimental: Arm 3A - Tucatinib + trastuzumab + ramucirumab + paclitaxel
Active comparator: Arm 3B - Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo
Experimental: Arm 3C - Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo
Treatment: Drugs: tucatinib
300 mg given twice daily orally
Treatment: Drugs: trastuzumab
6 mg/kg loading dose will be administered intravenously (IV; into the vein) on Cycle 1 Day 1, followed by 4 mg/kg IV on Cycle 1 Day 15 and then Days 1 and 15 of each cycle thereafter
Treatment: Drugs: ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
Treatment: Drugs: paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
Other interventions: tucatinib placebo
Given twice daily orally
Other interventions: trastuzumab placebo
IV on Days 1 and 15 of each cycle
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose-limiting Toxicities (DLT) During the First Cycle of Treatment
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Assessment method [1]
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DLTs were adverse events (AEs), laboratory abnormalities, or treatment modifications that occurred during the first cycle of treatment in the Phase 2 paclitaxel dose optimization stage that were related to paclitaxel, to tucatinib, or to the combination of tucatinib, trastuzumab, ramucirumab and paclitaxel and that met any of the study protocol specified criteria. The relationship of AEs to study drugs was determined by the investigator. AEs that were attributed only to trastuzumab and/or ramucirumab, but not tucatinib or paclitaxel were not considered DLTs.
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Timepoint [1]
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Cycle 1 (28 days)
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Primary outcome [2]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab, ramucirumab, or paclitaxel) and up to 30 days after the last dose of study treatment (tucatinib, trastuzumab, ramucirumab, or paclitaxel, whichever was later).
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Timepoint [2]
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From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)
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Primary outcome [3]
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Number of Participants With Treatment-emergent Laboratory Abnormalities
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Assessment method [3]
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Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. Laboratory abnormalities included: 1) Blood chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased, calcium corrected for albumin increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium decreased, magnesium increased, potassium decreased, potassium increased, sodium decreased, sodium increased, and total bilirubin increased; 2) Hematological: hemoglobin decreased, leukocytes decreased, lymphocytes decreased, neutrophils decreased, and platelets decreased.
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Timepoint [3]
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From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)
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Primary outcome [4]
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Number of Participants With Clinically Significant Vital Signs Values
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Assessment method [4]
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Vital sign examinations included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate. Criteria: SBP greater than or equal to (\>=) 120 millimeters of mercury (mm Hg) or DBP \>= 80 mm Hg; SBP \>= 140 mm Hg or DBP \>= 90 mm Hg; SBP \>= 160 mm Hg or DBP \>= 100 mm Hg), heart rate greater than (\>) 100 beats per minute (min). Clinical significance in vital signs abnormalities was judged by investigator. In this outcome measure number of participants with at least 1 clinically significant abnormality in any vital sign are reported.
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Timepoint [4]
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From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)
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Primary outcome [5]
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Maximum Percentage Change From Baseline in Weight
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Assessment method [5]
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Maximum percentage decrease from baseline in weight is reported in this outcome measure.
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Timepoint [5]
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From Baseline (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)
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Primary outcome [6]
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Number of Participants With Any Dose Modifications
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Assessment method [6]
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Dose modification included dose hold, dose reduction, dose error and unplanned dose adjustments. Number of participants with any dose treatment modifications for paclitaxel, ramucirumab, trastuzumab, and tucatinib are reported in this outcome measure.
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Timepoint [6]
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From first dose of the study treatment (Day 1) up to the last dose of study treatment (maximum treatment duration up to 19.8 months)
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Secondary outcome [1]
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 By Investigator Assessment
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Assessment method [1]
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ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v 1.1 by investigator assessment. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As per RECIST v1.1, disease progression (PD) was defined as one of the following: at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
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Timepoint [1]
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From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 19.8 months)
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Secondary outcome [2]
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Confirmed ORR Per RECIST v1.1 By Investigator Assessment
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Assessment method [2]
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Confirmed ORR was defined as the percentage of participants with best overall response of confirmed CR or PR according to RECIST v1.1 by investigator assessment. For a response to be confirmed, the subsequent response needs to be at least 4 weeks after the initial response. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As per RECIST v1.1, disease progression (PD) was defined as one of the following: at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
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Timepoint [2]
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From the first dose of study treatment until the first documented confirmed CR or PR or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 19.8 months)
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Secondary outcome [3]
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Progression-Free Survival (PFS) Per RECIST v1.1 By Investigator Assessment
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Assessment method [3]
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PFS was defined as the time from the date of treatment initiation to the date of documented PD or death from any cause, whichever occurred first per RECIST version 1.1 by investigator assessment. As per RECIST v1.1, disease progression (PD) was defined as one of the following: at least a 20% increase in the sum of diameters (SOD) of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. Participants without documentation of PD or death at the time of analysis were censored at the date of the last tumor assessment. Kaplan-Meier method was used for evaluation.
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Timepoint [3]
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From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (up to 19.8 months)
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Secondary outcome [4]
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Duration of Response (DOR) Per RECIST v1.1 By Investigator Assessment
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Assessment method [4]
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DOR: time from first documentation of objective response of CR or PR to first documentation of PD or death from any cause, whichever occurred first according to RECIST v1.1 by investigator assessment. As per RECIST v1.1, CR: disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. PD was defined as one of the following: at least a 20% increase in sum of diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5mm, unequivocal progression of existing non-target lesions, or appearance of one or more new lesions. Participants without documentation of PD or death at time of analysis were censored at the date of last tumor assessment. Kaplan-Meier method was used for evaluation.
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Timepoint [4]
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From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (up to 19.8 months)
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Secondary outcome [5]
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Disease Control Rate (DCR) Per RECIST v1.1 By Investigator Assessment
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Assessment method [5]
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DCR was defined as percentage of participants with CR, PR, or stable disease (SD or non-CR/non-progressive disease) according to RECIST v1.1 by investigator assessment. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as one of following: at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5mm, unequivocal progression of existing non-target lesions, or appearance of one or more new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters.
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Timepoint [5]
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From the first dose study treatment until PD or death, whichever occurred first (up to 19.8 months)
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Secondary outcome [6]
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Area Under the Plasma Concentration-time Curve to the Time of the Last Quantifiable Concentration (AUClast) of Paclitaxel, Tucatinib and Their Metabolites
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Assessment method [6]
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AUClast was reported for tucatinib, tucatinib metabolite (ONT-993), paclitaxel and paclitaxel metabolites (6 alpha-hydroxy-paclitaxel, 3'-p-hydroxy-paclitaxel and 6 alpha-3'-p-Dihydroxy-paclitaxel).
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Timepoint [6]
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Tucatinib and ONT-993- Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 2, 4, 6, 8 hours post-dose; Paclitaxel and its metabolites- Cycle 1 Days 1 and 8, Cycle 2 Day 1: Pre-dose, 2, 4, 6, 8 hours post-dose (each cycle length=28 days)
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Secondary outcome [7]
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Maximum Observed Plasma Concentration (Cmax)
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Assessment method [7]
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Cmax was reported for tucatinib and tucatinib metabolite ONT-993.
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Timepoint [7]
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Tucatinib and ONT-993- Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 2, 4, 6, 8 hours post-dose (each cycle length=28 days)
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Secondary outcome [8]
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Time to Maximum Observed Plasma Concentration (Tmax)
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Assessment method [8]
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Tmax was reported for tucatinib and tucatinib metabolite ONT-993.
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Timepoint [8]
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Tucatinib and ONT-993- Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 2, 4, 6, 8 hours post-dose (each cycle length=28 days)
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Secondary outcome [9]
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Trough Concentration (Ctrough)
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Assessment method [9]
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Ctrough was calculated for tucatinib and tucatinib metabolite ONT-993.
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Timepoint [9]
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Tucatinib and ONT-993- Cycle 1 Day 8, Cycle 2 Day 1: Predose (each cycle length=28 days)
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Secondary outcome [10]
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Metabolite Ratio Based on AUClast (MRAUClast)
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Assessment method [10]
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MRAUClast was defined as metabolic ratio, that is, ratio of the AUClast of a given paclitaxel metabolite over the AUClast of paclitaxel. MRAUClast for 6 alpha-hydroxypaclitaxel, 3-p-hydroxy-paclitaxel and 6 alpha-3-p-dihydroxy-paclitaxel was reported in this outcome measure.
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Timepoint [10]
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Paclitaxel and its metabolites- Cycle 1 Days 1 and 8, Cycle 2 Day 1: Pre-dose, 2, 4, 6, 8 hours post-dose (each cycle length=28 days)
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
* HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:
* Phase 2 paclitaxel dose optimization stage:
* HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
* HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 2 dose expansion stage:
* Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* History of prior treatment with a HER2-directed antibody
* Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
* Phase 2: Measurable disease according to RECIST version 1.1
* Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Life expectancy of at least 3 months, in the opinion of the investigator
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects with squamous cell or undifferentiated GEC
* Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
* Having received taxanes =12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
* Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
* Unable to swallow pills
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/04/2024
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Sample size
Target
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Accrual to date
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Final
17
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Central Coast Local Health District (Gosford and Wyong Hospitals) - Gosford
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Recruitment hospital [2]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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63V6 63 - Heidelberg
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
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0
Arizona
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0
0
United States of America
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State/province [3]
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0
California
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0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Iowa
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Nevada
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0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
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0
North Carolina
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0
0
United States of America
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State/province [14]
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0
Ohio
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Oregon
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Pennsylvania
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Country [17]
0
0
United States of America
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State/province [17]
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0
Tennessee
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Country [18]
0
0
United States of America
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State/province [18]
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0
Texas
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0
0
United States of America
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0
Utah
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0
0
United States of America
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0
Washington
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Country [21]
0
0
Canada
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State/province [21]
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0
Ontario
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Country [22]
0
0
Canada
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State/province [22]
0
0
Quebec
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Country [23]
0
0
Korea, Republic of
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State/province [23]
0
0
Busan
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Country [24]
0
0
Korea, Republic of
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State/province [24]
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0
Daegu
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Country [25]
0
0
Korea, Republic of
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State/province [25]
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0
Seongnam-si
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Country [26]
0
0
Korea, Republic of
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State/province [26]
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Seoul
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Country [27]
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0
Korea, Republic of
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State/province [27]
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0
Suwon-si
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Country [28]
0
0
Taiwan
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State/province [28]
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0
Kaohsiung
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Country [29]
0
0
Taiwan
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State/province [29]
0
0
Taipei
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Country [30]
0
0
United Kingdom
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State/province [30]
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0
London
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Country [31]
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0
United Kingdom
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State/province [31]
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0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.
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Trial website
https://clinicaltrials.gov/study/NCT04499924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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JoAl Mayor, PharmD, BCOP
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Address
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Seagen Inc.
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Country
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0
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Phone
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Fax
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0
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Email
0
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Contact person for public queries
Name
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Address
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0
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT04499924/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT04499924/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04499924
Download to PDF