A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00960960
First received: August 13, 2009
Last updated: March 4, 2014
Last verified: March 2014

August 13, 2009
March 4, 2014
August 2009
March 2014   (final data collection date for primary outcome measure)
Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
Complete list of historical versions of study NCT00960960 on ClinicalTrials.gov Archive Site
  • PK parameters of GDC-0941 and paclitaxel (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ] [ Designated as safety issue: No ]
  • PK parameters of GDC-0941 and paclitaxel (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ]
Not Provided
Not Provided
 
A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety And Pharmacology of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with intravenous (IV) paclitaxel with and without and IV bevacizumab or IV trastuzumab in patients with locally recurrent or metastatic breast cancer.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
  • Drug: trastuzumab
    Intravenous repeating dose
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
Experimental: 1
Interventions:
  • Drug: trastuzumab
  • Drug: bevacizumab
  • Drug: GDC-0941
  • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
  • Adequate organ and bone marrow function as assessed by laboratory tests
  • Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  • Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

  • History of Grade >/= 3 fasting hyperglycemia
  • History of diabetes requiring regular medication
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
  • Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
  • Uncontrolled current illness
  • Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • Known HIV infection
  • New York Heart Association (NYHA) Class II or greater congestive heart failure
  • Active ventricular arrhythmia requiring medication
  • Pregnancy, lactation, or breastfeeding
  • Known significant hypersensitivity to study drugs or excipients
  • History of arterial thromboembolic disease within 6 months of first study treatment
  • No more than two prior chemotherapy regimens for metastatic disease
  • No prior taxane therapy for metastatic disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Italy
 
NCT00960960
GDC4629g, GO01304
Not Provided
Genentech
Genentech
Not Provided
Study Director: Gallia Levy, M.D., Ph.D. Genentech
Genentech
March 2014

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