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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04060862




Registration number
NCT04060862
Ethics application status
Date submitted
13/08/2019
Date registered
19/08/2019

Titles & IDs
Public title
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Scientific title
A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Secondary ID [1] 0 0
2019-001072-11
Secondary ID [2] 0 0
CO41012
Universal Trial Number (UTN)
Trial acronym
IPATunity150
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Placebo
Treatment: Drugs - Palbociclib
Treatment: Drugs - Fulvestrant

Experimental: Phase 1b and Phase 3: Ipatasertib + Palbociclib +Fulvestrant -

Placebo comparator: Phase 3: Placebo + Palbociclib + Fulvestrant -


Treatment: Drugs: Ipatasertib
Phase 1b: Ipatasertib, 300 mg starting dose administered orally once daily (PO QD) during an initial 5-7 day run-in period, then continued on Days 1-21 during the first cycle. Starting with Cycle 2, Day 1 ipatasertib will be taken orally once daily on Days 1-21 of each 28-day cycle. Phase 3: Ipatasertib, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.

Treatment: Drugs: Placebo
Phase 3: Matching placebo, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.

Treatment: Drugs: Palbociclib
Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle.

Treatment: Drugs: Fulvestrant
Fulvestrant, 500 mg administered as two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase III: Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
From randomization in Phase III until the first occurrence of disease progression or death from any cause, whichever occurs first, up to approximately 36 months
Secondary outcome [1] 0 0
Phase Ib: Number of Participants With Adverse Events and Adverse Events With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Timepoint [1] 0 0
Up to 36 Months
Secondary outcome [2] 0 0
Phase Ib: Plasma Concentration of Ipatasertib and Its Metabolite G-037720
Timepoint [2] 0 0
Cycle 1, Day 1 and 15: 0.25 hours pre-dose, 0.5, 1, 2, 3, 4 and 6 hours post- dose ; Cycle 2, Day 15: 0.25 hours pre-dose; Cycle 3, Day 15: 0.15 hours pre-dose, 2 hours post-dose (each cycle = 28 days)
Secondary outcome [3] 0 0
Phase Ib: Maximum Concentration (Cmax) of Ipatasertib and Its Metabolite G-037720 in Plasma
Timepoint [3] 0 0
Cycle 1: Day 1 and Day 15
Secondary outcome [4] 0 0
Phase Ib: Area Under the Plasma Concentration Time-curve From Zero to 24 Hours (AUC0-24) of Ipatasertib and Its Metabolite G-037720
Timepoint [4] 0 0
Cycle 1: Day 1 and Day 15
Secondary outcome [5] 0 0
Phase Ib: Time to Maximum Concentration (Tmax) of Ipatasertib and Its Metabolite G-037720
Timepoint [5] 0 0
Cycle 1: Day 1 and Day 15
Secondary outcome [6] 0 0
Phase III: Objective Response Rate (ORR) as Determined by the Investigator According to RECIST v1.1
Timepoint [6] 0 0
From randomization in Phase III up to approximately 36 months
Secondary outcome [7] 0 0
Phase III: Duration of Objective Response (DOR) as Determined by the Investigator According to RECIST v1.1
Timepoint [7] 0 0
From randomization in Phase III until the first occurrence of disease progression or death from any cause, whichever occurs first, up to approximately 36 months
Secondary outcome [8] 0 0
Phase III: Clinical Benefit Rate (CBR) as Determined by the Investigator According to RECIST v1.1
Timepoint [8] 0 0
From randomization in Phase III until the first occurrence of disease progression or death from any cause, whichever occurs first, up to approximately 36 months
Secondary outcome [9] 0 0
Phase III: Overall Survival (OS) as Determined by the Investigator According to RECIST v1.1
Timepoint [9] 0 0
From randomization in Phase III until the first occurrence of disease progression or death from any cause, whichever occurs first, up to approximately 36 months
Secondary outcome [10] 0 0
Phase III: Time to Deterioration (TTD) in Severity of Pain, According to the Brief Pain Inventory-Short Form (BPI-SF)
Timepoint [10] 0 0
From randomization in Phase III to the first documentation of a =2-point increase in pain scale (up to approximately 36 months)
Secondary outcome [11] 0 0
Phase III: TTD in Presence and Interference of Pain According to the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Pain Scale
Timepoint [11] 0 0
From randomization in Phase III to the first documentation of a =10-point increase (up to approximately 36 months)
Secondary outcome [12] 0 0
Phase III: TTD in Physical Functioning (PF), Role Functioning (RF), GHS/QoL According to EORTC QLQ-C30
Timepoint [12] 0 0
From randomization in Phase III to the first documentation of a =10-point decrease in the PF, RF and GHS/QoL of EORTC QLQ-C30 (up to approximately 36 months)
Secondary outcome [13] 0 0
Phase III: Number of Participants With Adverse Events
Timepoint [13] 0 0
Up to approximately 36 months

Eligibility
Key inclusion criteria
* HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm
* Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer
* At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1
* Phase III only: Tumor specimen from the most recently collected, available tumor tissue
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant
* Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
* Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
* Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer
* Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
* History of Type I or Type II diabetes mellitus requiring insulin
* History of or active inflammatory bowel disease or active bowel inflammation
* Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/08/2023
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cabrini Medical Centre; Oncology - Malvern
Recruitment hospital [2] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Japan
State/province [9] 0 0
Fukuoka
Country [10] 0 0
Japan
State/province [10] 0 0
Kanagawa
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Valencia
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Manchester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
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
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


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/NCT04060862