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
NCT ID: NCT01862081
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2013-07-16
2017-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: GDC-0032 + Docetaxel
Participants 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.
Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Arm B: GDC-0032 + Paclitaxel
Participants 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.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Paclitaxel
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Arm C: GDC-0032 + Docetaxel
Participants 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.
Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Arm D: GDC-0032 + Docetaxel
Participants 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.
Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Arm E: GDC-0032 + Docetaxel
Participants 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.
Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Arm F: GDC-0032 + Paclitaxel
Participants 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.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Paclitaxel
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Arm G: GDC-0032 + Paclitaxel
Participants 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.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Paclitaxel
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Interventions
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Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Paclitaxel
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology, P.A; Baylor Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy
Leuven, , Belgium
Princess Margaret Hospital
Toronto, Ontario, Canada
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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2013-003543-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27802
Identifier Type: -
Identifier Source: org_study_id