To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | December 13, 2016 |
End Date: | February 29, 2020 |
Contact: | Reference Study ID Number: GO39374 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Hormone-Receptor Positive Breast Cancer
This is an open-label, multicenter, Phase I study designed to evaluate the safety,
tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in
participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate
3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and
in combination with standard-of-care endocrine and targeted therapies for the treatment of
locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal
growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two
stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants
will be assigned to one of six regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in
combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole
(Arm C), GDC-0077 in combination with fulvestrant (Arm D), GDC-0077 in combination with
palbociclib and fulvestrant (Arm E), and GDC-0077 in combination with palbociclib,
fulvestrant, and metformin (Arm F).
tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in
participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate
3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and
in combination with standard-of-care endocrine and targeted therapies for the treatment of
locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal
growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two
stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants
will be assigned to one of six regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in
combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole
(Arm C), GDC-0077 in combination with fulvestrant (Arm D), GDC-0077 in combination with
palbociclib and fulvestrant (Arm E), and GDC-0077 in combination with palbociclib,
fulvestrant, and metformin (Arm F).
Inclusion Criteria:
- Evaluable or measurable disease per RECIST, Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of greater than or equal to (≥) 12 weeks
- Adequate hematologic and organ function, including blood counts, liver and kidney
function
Stage I Arm A (GDC-0077):
- Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor
malignancy, including breast cancer
Stages I and II, Arms B and C, or Stage II Arm D:
- Postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant
HR+/HER2- breast cancer
Stage II, Arms E or F:
- Female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast
cancer
Stages I and II:
- All participants must provide tumor tissue from the primary or metastatic tumor site
obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA
mutation by central laboratory test.
Exclusion Criteria:
- Inflammatory or metaplastic breast cancer
- History of leptomeningeal disease
- Type 1 or 2 diabetes requiring anti-hyperglycemic medication
- Inability or unwillingness to swallow pills
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known and untreated, or active central nervous system metastases
- Uncontrolled pleural effusion or ascites
- History of other malignancy within 5 years, except for treated carcinoma in situ of
the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- History of or active ventricular dysrhythmias or congestive heart failure requiring
medication or symptomatic coronary heart disease
- Congenital long QT syndrome, prolonged QT interval, or family history of sudden
unexplained death or long QT syndrome
Stage II:
- Stage II Arms B, C, D, and E only: Prior treatment with >1 chemotherapy regimen for
metastatic disease
- Prior treatment with PI3K inhibitor
- History of significant toxicity related to mTOR inhibitor requiring treatment
discontinuation
- Stage II Arms B and E only: prior CDK4/6 inhibitor treatment
We found this trial at
6
sites
3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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