A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2017 |
Start Date: | July 16, 2013 |
End Date: | June 9, 2017 |
This is an open-label, multicenter, dose-escalation study designed to assess the safety,
tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either
docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have
HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer
(NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal
growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There
are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and
a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm
has been established from dose escalation, additional patients with each combination will be
enrolled in Stage 2.
tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either
docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have
HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer
(NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal
growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There
are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and
a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm
has been established from dose escalation, additional patients with each combination will be
enrolled in Stage 2.
Inclusion Criteria:
- Age >=18 years
- For paclitaxel combination arms: histologically or cytologically documented
adenocarcinoma of the breast with locally recurrent or metastatic disease
- For docetaxel combination arms: histologically or cytologically documented
adenocarcinoma of the breast with locally recurrent or metastatic disease or
histologically documented advanced (Stage IV) or recurrent NSCLC
- For participants with breast cancer: HER2-negative disease as defined by local
clinical guidelines
- Participants with NSCLC to be treated with docetaxel need to have received at least
one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel
be considered appropriate treatment
- Evaluable or measurable disease per response evaluation criteria in solid tumors
(RECIST) v.1.1
- Life expectancy >=12 weeks
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
- Adequate hematologic and end organ function
- Use of highly effective form of contraception
Exclusion Criteria:
- Prior anti-cancer therapy
- Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
- Known significant hypersensitivity to any components of study treatment
- Grade >=2 peripheral neuropathy
- Type 1 or Type 2 diabetes
- Grade >=2 hypercholesterolemia or hypertriglyceridemia
- Congenital long QT syndrome
- Active congestive heart failure or ventricular arrhythmia
We found this trial at
11
sites
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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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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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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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
Tampa, Florida 33607
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