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

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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.


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
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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1211 Medical Center Dr
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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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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Boston, MA
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Dallas, TX
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Fort Worth, Texas 76104
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Fort Worth, TX
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Leuven,
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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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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
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Tampa, FL
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2811 Tieton Drive
Yakima, Washington 98902
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Yakima, WA
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