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)

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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).


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
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3322 West End Avenue
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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Nashville, TN
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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610 University Avenue
Toronto, Ontario M5G 2M9
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Toronto,
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