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

May 22, 2013
June 2, 2014
August 2013
January 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01862081 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: GDC-0032
    Stage 1: escalating doses of GDC-0032; Stage 2: maximum tolerated dose of GDC-0032
  • Drug: Docetaxel
    Docetaxel intravenously
  • Drug: Paclitaxel
    Paclitaxel intravenously
  • Experimental: Arm A: GDC-0032 + Docetaxel
    Interventions:
    • Drug: GDC-0032
    • Drug: Docetaxel
  • Experimental: Arm B: GDC-0032 + Paclitaxel
    Interventions:
    • Drug: GDC-0032
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Reference Study ID Number: GO27802 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01862081
GO27802
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP