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
2 other identifiers
interventional
80
4 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2013
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedStudy Start
First participant enrolled
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2017
CompletedNovember 28, 2017
November 1, 2017
3.9 years
May 22, 2013
November 27, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Safety: Incidence of adverse events
Approximately 3 years
Safety: Incidence of dose limiting toxicities
Up to 28 days
Secondary Outcomes (7)
Area under the curve from time 0 to the last measurable concentration (AUC0-last)
Up to 28 days
Time to maximum observed plasma concentration (Tmax)
Up to 28 days
Maximum observed plasma concentration (Cmax)
Up to 28 days
Minimum observed plasma concentration (Cmin)
Up to 28 days
Objective response according to RECIST v1.1
Approximately 3 years
- +2 more secondary outcomes
Study Arms (7)
Arm A: GDC-0032 + Docetaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily for 21 consecutive days (beginning from Day 1) in each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Arm B: GDC-0032 + Paclitaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily for 28 consecutive days (beginning from Day 1) in each 28-day cycle along with Paclitaxel on Days 1, 8, 15 and 22 of each 28-day cycle.
Arm C: GDC-0032 + Docetaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily on Day 1 and Days 8-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Arm D: GDC-0032 + Docetaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily on Days 2-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Arm E: GDC-0032 + Docetaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily on Days 1-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Arm F: GDC-0032 + Paclitaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily on a 5-days on, 2-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle.
Arm G: GDC-0032 + Paclitaxel
EXPERIMENTALParticipants will receive GDC-0032 once daily on a 3-days on, 4-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle.
Interventions
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (14)
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, 33607, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology, P.A; Baylor Sammons Cancer Center
Dallas, Texas, 75231, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, 76104, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy
Leuven, 3000, Belgium
Princess Margaret Hospital
Toronto, Ontario, M4X 1K9, Canada
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 24, 2013
Study Start
July 16, 2013
Primary Completion
June 9, 2017
Study Completion
June 9, 2017
Last Updated
November 28, 2017
Record last verified: 2017-11