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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01862081
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer, Non-small Lung Cancer Drug: Docetaxel Drug: GDC-0032 Drug: Paclitaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 16, 2013
Actual Primary Completion Date : June 9, 2017
Actual Study Completion Date : June 9, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.

Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Experimental: 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.
 Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.

Drug: Paclitaxel
Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Experimental: 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.
 Drug: Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.

Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Experimental: 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.
 Drug: Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.

Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Experimental: 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.
 Drug: Docetaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.

Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Experimental: 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.
 Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.

Drug: Paclitaxel
Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Experimental: 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.
 Drug: GDC-0032
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.

Drug: Paclitaxel
Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: Approximately 3 years ]
  2. Safety: Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Area under the curve from time 0 to the last measurable concentration (AUC0-last) [ Time Frame: Up to 28 days ]
  2. Time to maximum observed plasma concentration (Tmax) [ Time Frame: Up to 28 days ]
  3. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 28 days ]
  4. Minimum observed plasma concentration (Cmin) [ Time Frame: Up to 28 days ]
  5. Objective response according to RECIST v1.1 [ Time Frame: Approximately 3 years ]
  6. Duration of response according to RECIST v1.1 [ Time Frame: Approximately 3 years ]
  7. Progression-free survival (PFS) according to RECIST v1.1 [ Time Frame: Approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862081


Locations
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United States, Florida
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, United States, 33607
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A; Baylor Sammons Cancer Center
Dallas, Texas, United States, 75231
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Belgium
UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy
Leuven, Belgium, 3000
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M4X 1K9
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01862081    
Other Study ID Numbers: GO27802
2013-003543-28 ( EudraCT Number )
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Paclitaxel
Docetaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action