Breast Cancer, Non-small Lung Cancer Clinical Trial
| Verified date | November 2017 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | June 9, 2017 |
| Est. primary completion date | June 9, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy | Leuven | |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Texas Oncology, P.A; Baylor Sammons Cancer Center | Dallas | Texas |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Florida Cancer Specialists - Tampa (Dr. MLK Blvd) | Tampa | Florida |
| United States | Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Belgium, Canada, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Incidence of adverse events | Approximately 3 years | ||
| Primary | Safety: Incidence of dose limiting toxicities | Up to 28 days | ||
| Secondary | Area under the curve from time 0 to the last measurable concentration (AUC0-last) | Up to 28 days | ||
| Secondary | Time to maximum observed plasma concentration (Tmax) | Up to 28 days | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to 28 days | ||
| Secondary | Minimum observed plasma concentration (Cmin) | Up to 28 days | ||
| Secondary | Objective response according to RECIST v1.1 | Approximately 3 years | ||
| Secondary | Duration of response according to RECIST v1.1 | Approximately 3 years | ||
| Secondary | Progression-free survival (PFS) according to RECIST v1.1 | Approximately 3 years |