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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03353753




Registration number
NCT03353753
Ethics application status
Date submitted
20/11/2017
Date registered
27/11/2017

Titles & IDs
Public title
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Scientific title
A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies
Secondary ID [1] 0 0
DCC-2618-03-001
Universal Trial Number (UTN)
Trial acronym
INVICTUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DCC-2618
Treatment: Drugs - Placebo Oral Tablet

Active comparator: Arm 1 - 150 mg QD DCC-2618

Placebo comparator: Arm 2 - Placebo


Treatment: Drugs: DCC-2618
Oral KIT/PDGFRA kinase inhibitor

Treatment: Drugs: Placebo Oral Tablet
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Secondary outcome [2] 0 0
Time to Tumor Progression (TTP) Based on Independent Radiologic Review
Timepoint [2] 0 0
From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Secondary outcome [4] 0 0
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
Timepoint [4] 0 0
From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Secondary outcome [5] 0 0
Quality of Life & Disease-Related Symptoms - Physical Functioning
Timepoint [5] 0 0
From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Secondary outcome [6] 0 0
Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
Timepoint [6] 0 0
From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)

Eligibility
Key inclusion criteria
1. Histologic diagnosis of GIST
2. Patients must have progressed on imatinib, sunitinib, and regorafenib or have documented intolerance to any of these treatments.
3. ECOG PS of 0 to 2 at screening.
4. Able to provide an archival tumor tissue sample if no anticancer therapy was administered since the sample was collected; otherwise, a fresh tumor tissue sample is required prior to the first dose of study drug.
5. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotrophin (ß-hCG) pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
6. Patients of reproductive potential must agree to follow the contraception requirements.
7. The patient is capable of understanding and complying with the protocol and has signed the informed consent document. A signed informed consent form must be obtained before any study-specific procedures are performed.
8. At least 1 measurable lesion according to modified RECIST Version 1.1 (non-nodal lesions must be =1.0 cm in the long axis or =double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.
9. Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed at screening.

* Absolute neutrophil count =1000/uL
* Hemoglobin =8 g/dL
* Platelet count =75,000/uL
* Total bilirubin =1.5 x the upper limit of normal (ULN)
* Aspartate transaminase or alanine transaminase =3 x ULN (=5x ULN in the presence of hepatic metastases)
* Serum creatinine =1.5 x ULN or creatinine clearance =50 mL/min based on either urine collection or Cockcroft Gault estimation.
* Prothrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time =1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization.
10. Resolution of all toxicities from prior therapy to =Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and =Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug. For prior biological therapies, eg, monoclonal antibodies with a half-life longer than 3 days, the interval must be at least 28 days prior to the first dose of study drug.
2. Prior treatment with DCC-2618
3. Prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of DCC-2618. Patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol.
4. Patient has known active central nervous system metastases.
5. New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
7. Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 3 months before the first dose of study drug. Patients with venous thrombotic events =3 months before the first dose of study drug on stable anticoagulation therapy are eligible.
8. 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval corrected syndrome.
9. Left ventricular ejection fraction (LVEF) <50% at screening.
10. Use of proton-pump inhibitors within 4 days prior to the first dose of study drug. Other medications that increase gastric pH, ie, histamine H2 receptor antagonists and antacids may be taken provided they are not administered within 2 hours before or after administration of study drug.
11. Use of strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4, including certain herbal medications (eg, St. John's Wort) and consumption of grapefruit or grapefruit juice within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
12. Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
13. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. Following major surgeries, >4 weeks prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence.
14. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
15. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
16. If female, the patient is pregnant or lactating.
17. Known allergy or hypersensitivity to any component of the investigational drug product. Patients with a history of Stevens-Johnson syndrome on a prior TKI are excluded.
18. Gastrointestinal abnormalities including but not limited to:

* inability to take oral medication
* malabsorption syndromes
* requirement for intravenous alimentation
19. Any active bleeding excluding hemorrhoidal or gum bleeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/05/2022
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Villejuif
Country [19] 0 0
Germany
State/province [19] 0 0
Brandenburg
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Mannheim
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Rome
Country [24] 0 0
Netherlands
State/province [24] 0 0
Leiden
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Seville
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Deciphera Pharmaceuticals, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03353753