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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01862081
First received: May 22, 2013
Last updated: November 23, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Breast Cancer, Non-small Lung Cancer
Drug: Docetaxel
Drug: GDC-0032
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination With Either Docetaxel or Paclitaxel in Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer or Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve from time 0 to the last measurable concentration (AUC0-last) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration (Tmax) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration (Cmin) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Objective response according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862081

Locations
United States, Florida
Tampa, Florida, United States, 33607
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Tennessee
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37212
United States, Texas
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76104
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Yakima, Washington, United States, 98902
Belgium
Leuven, Belgium, 3000
Canada, Ontario
Toronto, Ontario, Canada, M4X 1K9
Spain
Barcelona, Spain, 08035
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01862081     History of Changes
Other Study ID Numbers: GO27802  2013-003543-28 
Study First Received: May 22, 2013
Last Updated: November 23, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016