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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01254526
First received: December 1, 2010
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: bevacizumab
Drug: GDC-0980
Drug: paclitaxel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Escalation 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through Day 22 ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion, up to 1 year, or early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life) [ Time Frame: Through Day 22 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0980
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose
Experimental: B Drug: bevacizumab
Intravenous repeating dose
Drug: GDC-0980
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

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

Inclusion Criteria:

  • Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
  • For Arm C: Overexpression of HER2
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate hematologic and organ function
  • Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
  • Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study

Exclusion Criteria:

  • Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
  • Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
  • History of Type 1 or Type 2 diabetes requiring regular medication
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Any condition requiring full-dose anticoagulants
  • Leptomeningeal disease as a manifestation of cancer
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of <= 10 mg/day of prednisone
  • Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
  • Known HIV infection
  • Known untreated or active CNS metastases
  • Pregnancy, lactation, or breastfeeding
  • Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment

For Arm B:

  • Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment
  • Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment
  • History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254526

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Tennessee
Nashville, Tennessee, United States, 37203
Belgium
Leuven, Belgium, 3000
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jennifer Lauchle, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01254526     History of Changes
Other Study ID Numbers: PIM4880g, GO00882
Study First Received: December 1, 2010
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013