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An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
TGen Clinical Research Srvs
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
UC Davis; Comprehensive Cancer Center
Sacramento, California, United States
Sutter Health
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, United States
Sarah Cannon Res Inst; FL
Sarasota, Florida, United States
Univ of Chicago
Chicago, Illinois, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Maine, United States
Start Date
March 16, 2011
Primary Completion Date
June 25, 2021
Completion Date
June 25, 2021
Last Updated
July 31, 2024
674
ACTUAL participants
Fulvestrant
DRUG
GDC-0032
DRUG
Letrozole
DRUG
Midazolam
DRUG
Lead Sponsor
Genentech, Inc.
NCT07186842
NCT03514368
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07371663