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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04177108




Registration number
NCT04177108
Ethics application status
Date submitted
7/11/2019
Date registered
26/11/2019
Date last updated
17/06/2020

Titles & IDs
Public title
A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.
Scientific title
A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.
Secondary ID [1] 0 0
2019-000810-12
Secondary ID [2] 0 0
CO41101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple-Negative 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 - Atezolizumab
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Placebo for Atezolizumab
Treatment: Drugs - Placebo for Ipatasertib

Experimental: Cohort 1 Arm A - PD-L1 Non-Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1:1 ratio.

Experimental: Cohort 1 Arm B - PD-L1 Non-Positive Participants receiving Paclitaxel, Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.

Active Comparator: Cohort 1 Arm C - PD-L1 Non-Positive Participants receiving Paclitaxel, Placebo for Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.

Experimental: Cohort 2 Arm A - PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1 ratio.

Active Comparator: Cohort 2 Arm B - PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Placebo for Ipatasertib. Participants will be randomised in a 1:1 ratio.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered to participants by intravenous (IV) infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.

Treatment: Drugs: Ipatasertib
Ipatasertib will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered to participants at a starting dose of 80 mg/m^2 by IV infusion for 3 of 4 weeks on Days 1, 8, and 15 of each 28-day cycle unless deferred to Day 22 because of an adverse event.

Treatment: Drugs: Placebo for Atezolizumab
Placebo will be administered to participants at a fixed dose of 840 mg IV infusion for Atezolizumab on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.

Treatment: Drugs: Placebo for Ipatasertib
Placebo will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for Ipatasertib for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.

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

Outcomes
Primary outcome [1] 0 0
Investigator-assessed Progression Free Survival (PFS) - Defined as the time from randomisation to the first occurrence of disease progression, as determined locally according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first.
Timepoint [1] 0 0
Up to 76 months
Primary outcome [2] 0 0
Overall Survival (OS) - Defined as the time from randomisation to death from any cause.
Timepoint [2] 0 0
Up to 76 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) - Defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1.
Timepoint [1] 0 0
Up to 76 months
Secondary outcome [2] 0 0
Duration of Response (DOR) - Defined as the time from the first occurrence of a documented objective response to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
Timepoint [2] 0 0
Up to 76 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) - Defined as the proportion of participants who have a CR, PR, or stable disease for >= 24 weeks, as determined by the investigator according to RECIST v1.1.
Timepoint [3] 0 0
Up to 76 months
Secondary outcome [4] 0 0
Mean and mean changes from baseline score in participant-reported function (role, physical) - Assessed by EORTC QLC-C30 Selected Scales: Physical Function (Questions 1-5) and Role Function (Questions 6 and 7).
Timepoint [4] 0 0
Up to 76 months
Secondary outcome [5] 0 0
Mean and mean changes from baseline score in function in participant-reported Global Health Status (GHS)/Quality of Life (QoL) by assessment timepoint and between treatment arms - Assessed by EORTC QLC-C30 Selected Scale: GHS/QoL (Questions 29 and 30).
Timepoint [5] 0 0
Up to 76 months
Secondary outcome [6] 0 0
Progression Free Survival (PFS) for participants with Programmed Death-Ligand 1 (PD-L1)-non-positive tumors - Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Timepoint [6] 0 0
Up to 76 months
Secondary outcome [7] 0 0
Overall Survival (OS) for participants with PD-L1-non-positive tumors - Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Timepoint [7] 0 0
Up to 76 months
Secondary outcome [8] 0 0
Overall Response Rate (ORR) for participants with PD-L1-non-positive tumors - Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Timepoint [8] 0 0
Up to 76 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS) for participants with PIK3CA/AKT1/PTEN-altered tumors - Participants in experimental treatment arm will be compared with participants in control treatment arm.
Timepoint [9] 0 0
Up to 76 months
Secondary outcome [10] 0 0
Overall Survival (OS) for participants with PIK3CA/AKT1/PTEN-altered tumors - Participants in experimental treatment arm will be compared with participants in control treatment arm.
Timepoint [10] 0 0
Up to 76 months
Secondary outcome [11] 0 0
Overall Response Rate (ORR) for participants with PIK3CA/AKT1/PTEN-altered tumors - Participants in experimental treatment arm will be compared with participants in control treatment arm.
Timepoint [11] 0 0
Up to 76 months
Secondary outcome [12] 0 0
Duration of Response (DOR) for participants with PIK3CA/AKT1/PTEN-altered tumors - Participants in experimental treatment arm will be compared with participants in control treatment arm.
Timepoint [12] 0 0
Up to 76 months
Secondary outcome [13] 0 0
Number of Participants with Adverse Events (AEs) - Severity determined by the investigator according to the NCI Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Timepoint [13] 0 0
Up to 79 months
Secondary outcome [14] 0 0
Plasma concentration of ipatasertib and its metabolite (G037720) (ng/mL) at specified timepoints
Timepoint [14] 0 0
Up to 77 months
Secondary outcome [15] 0 0
Serum concentration of atezolizumab (µg/mL) at specified timepoints
Timepoint [15] 0 0
Up to 77 months
Secondary outcome [16] 0 0
Level of Anti-Drug Antibodies (ADAs) (%) to Atezolizumab
Timepoint [16] 0 0
Up to 76 months

Eligibility
Key inclusion criteria
1. Willingness and ability to complete all study-related assessments, including PRO
assessments, in the investigator's judgement.

2. Adequate hematologic and organ function within 14 days before the first study
treatment on Day 1 of Cycle 1.

3. Life expectancy of at least 6 months.

4. Measurable disease according to RECIST v1.1.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

6. For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, and agreement to refrain from donating
eggs.

7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive methods, and agreement to refrain from donating sperm.

8. Appropriate candidate for paclitaxel monotherapy if tumor PD-L1 status is unknown or
non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1
status is positive.

9. Histologically documented triple-negative adenocarcinoma of the breast that is locally
advanced or metastatic and is not amenable to resection with curative intent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to comply with study and follow-up procedures.

2. History of malabsorption syndrome or other condition that would interfere with enteral
absorption or results in the inability or unwillingness to swallow pills.

3. Active infection requiring systemic anti-microbial treatment (including antibiotics,
anti-fungal agents, and anti-viral agents).

4. Known HIV infection (there must be a negative HIV test at screening).

5. Known clinically significant history of liver disease consistent with Child-Pugh Class
B or C.

6. Current treatment with anti-viral therapy for HBV.

7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure
during the study.

8. Pregnancy or breastfeeding, or intention to become pregnant during the study or within
28 days after the final dose of ipatasertib/placebo, 5 months after the final dose of
atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs
later.

9. New York Heart Association Class II, III, or IV heart failure, left ventricular
ejection fraction < 50%, or active ventricular arrhythmia requiring medication.

10. Current unstable angina or history of myocardial infarction within 6 months prior to
Day 1 of Cycle 1.

11. Congenital long QT syndrome or screening QT interval corrected through use
Fridericia's formula (QTcF) > 480 ms.

12. Current treatment with medications used at doses known to cause clinically relevant
prolongation of QT/QTc interval.

13. History or presence of an abnormal ECG that is clinically significant in the
investigator's opinion (including complete left bundle branch block, second- or
third-degree heart block, or evidence of prior myocardial infarction).

14. Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents
for a chronic disease.

15. Treatment with approved or investigational cancer therapy within 14 days prior to Day
1 of Cycle 1.

16. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the investigator's opinion, gives reasonable suspicion of
a disease or condition that contraindicates the use of an investigational drug or that
may affect the interpretation of the results or renders the participant at high risk
from treatment complications.

17. History of or known presence of spinal cord metastases, as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or
prior radiographic assessments.

18. Known CNS disease, except for treated asymptomatic CNS metastases.

19. Known germline BRCA1/2 deleterious mutation, unless the participant is not an
appropriate candidate for a PARP-inhibitor.

20. Any previous systemic therapy for inoperable locally advanced or metastatic
triple-negative adenocarcinoma of the breast.

21. Unresolved, clinically significant toxicity from prior therapy, except for alopecia
and Grade 1 peripheral neuropathy.

22. Participants who have received palliative radiotherapy to peripheral sites (e.g., bone
metastases) for pain control and whose last treatment was completed 14 days prior to
Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute,
reversible effects (e.g., to Grade 1 or resolved by enrolment).

23. Uncontrolled pleural effusion, pericardial effusion or ascites.

24. Uncontrolled tumor-related pain.

25. Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except
for appropriately treated carcinoma in situ of the cervix, non-melanoma skin
carcinoma, or Stage I uterine cancer.

26. Known hypersensitivity or contraindication to any component of the study treatments,
including the paclitaxel excipient, macrogolglycerol ricinoleate.

27. Grade >= 2 peripheral neuropathy.

28. History of Type I or Type II diabetes mellitus requiring insulin.

29. Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.

30. History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative
colitis) or active bowel inflammation (e.g., diverticulitis).

31. Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis,
cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic
infections (pneumocystis pneumonia or cytomegalovirus pneumonia).

32. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5
drug-elimination half-lives, whichever is longer, prior to initiation of study drug.

33. Prior treatment with an Akt inhibitor.

34. Active or history of autoimmune disease or immune deficiency.

35. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan.

36. Prior allogeneic stem cell or solid organ transplantation.

37. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during treatment with
atezolizumab or within 5 months after the final dose of atezolizumab.

38. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins.

39. Known hypersensitivity to Chinese hamster ovary cell products or recombinant human
antibodies.

40. Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is
longer) prior to initiation of study treatment.

41. Treatment with systemic immunosuppressive medication (including, but not limited to
corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study
treatment, or anticipation of need for systemic immunosuppressive medication during
the study.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Mid North Coast Cancer Institute - Port Macquarie
Recruitment hospital [2] 0 0
Royal North Shore Hospital; Department of Medical Oncology - St Leonards
Recruitment hospital [3] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [7] 0 0
Monash Health Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [9] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment hospital [10] 0 0
St John of God Hospital; Bendat Cancer Centre - Subiaco
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
- St Albans
Recruitment postcode(s) [10] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arkansas
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California
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Colorado
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North Carolina
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Nasik
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Pune
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy and safety of ipatasertib in combination with
atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer
(TNBC) previously untreated in this setting.
Trial website
https://clinicaltrials.gov/show/NCT04177108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID: CO41101 http://www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04177108