Trial record 10 of 15 for:    GDC-0941

A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01740336
First received: November 30, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: GDC-0941
Drug: Placebo
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (PFS), defined as time from randomization to disease progression (tumor assessments according to RECIST v.1.1 criteria) or death from any cause [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Objective tumor response rate [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate, defined as partial response, complete response or stable disease lasting at least 6 months [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Duration of confirmed objective response [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Paclitaxel + GDC-0941 Drug: GDC-0941
orally daily for 5 consecutive days each week, followed by 2 days during which GDC-0941 is not administered (5/7-day schedule)
Drug: paclitaxel
90 mg/m2 IV weekly for 3 out of 4 weeks in every 28-day cycle
Active Comparator: B: Paclitaxel + Placebo Drug: Placebo
matching GDC-0941 placebo orally, 5/7-day schedule
Drug: paclitaxel
90 mg/m2 IV weekly for 3 out of 4 weeks in every 28-day cycle

  Eligibility

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

Inclusion Criteria:

  • Female adult patients
  • Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
  • Human epidermal growth factor receptor 2 (HER2)-negative and HR (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end organ function
  • Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer

Exclusion Criteria:

  • Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
  • Prior treatment with a PI3K inhibitor for advanced or metastatic breast cancer
  • History of intolerance to a taxane-containing therapy
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease
  • Active autoimmune disease or active inflammatory disease
  • Immunocompromised status
  • Need for current chronic corticosteroid therapy
  • Pregnancy, lactation, or breastfeeding
  • Current severe, uncontrolled systemic disease
  • Known untreated or active central nervous system (CNS) metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740336

Contacts
Contact: Reference Study ID Number: GO28509 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 102 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01740336     History of Changes
Other Study ID Numbers: GO28509, 2012-003262-41
Study First Received: November 30, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014