Trial record 2 of 7 for:    gdc0032

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01862081
First received: May 22, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered in combinat ion with either docetaxel (Arm A) or with paclitaxel (Arm B) in patients with HE R2-negative locally recurrent or metastatic breast cancer. Stage 1: Both Arms A and B will employ a dose-escalation design with escalating doses of GDC-0032.

Once the maximum tolerated dose of GDC-0032 has been established, additional pa tients will be enrolled in the cohort-expansion stage (Stage 2).


Condition Intervention Phase
Breast Cancer
Drug: GDC-0032
Drug: Docetaxel
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

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 [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: August 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: GDC-0032 + Docetaxel Drug: GDC-0032
Stage 1: escalating doses of GDC-0032; Stage 2: maximum tolerated dose of GDC-0032
Drug: Docetaxel
Docetaxel intravenously
Experimental: Arm B: GDC-0032 + Paclitaxel Drug: GDC-0032
Stage 1: escalating doses of GDC-0032; Stage 2: maximum tolerated dose of GDC-0032
Drug: Paclitaxel
Paclitaxel intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the breast with locally recurrent or metastatic disease
  • HER2-negative disease
  • Evaluable or measurable disease per 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

Exclusion Criteria:

  • Known significant hypersensitivity to any components of study treatment
  • Grade >= 2 peripheral neuropathy
  • Grade >= 2 hypercholesterolemia or hypertriglyceridemia
  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

Contacts
Contact: Reference Study ID Number: GO27802 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Florida
Recruiting
Tampa, Florida, United States, 33607
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02215
Recruiting
Boston, Massachusetts, United States, 02130
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Not yet recruiting
Albany, New York, United States, 12206
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Recruiting
Dallas, Texas, United States, 75231
Recruiting
Fort Worth, Texas, United States, 76104
United States, Virginia
Not yet recruiting
Norfolk, Virginia, United States, 23502
United States, Washington
Not yet recruiting
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01862081     History of Changes
Other Study ID Numbers: GO27802
Study First Received: May 22, 2013
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014