Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Genentech, Inc.
Study ID
NCT01254526
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDC-0980 — DRUG
    Oral repeating dose
  • bevacizumab — DRUG
    Intravenous repeating dose
  • paclitaxel — DRUG
    Intravenous repeating dose

Study Details

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.

Key Dates

First listed
Dec 6, 2010
Start date
Dec 31, 2010
Status verified
Nov 2016
Primary completion
Jul 31, 2012
Completion
Apr 30, 2013

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B

Primary Outcome Measure

Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through Day 22 ]

Locations (2)

FacilityCityStateZIPSite coordinators
-BostonMassachusetts02115-
-NashvilleTennessee37203-

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