Spots Global Cancer Trial Database for To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
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Trial Identification
Brief Title: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
Official Title: A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer
Study ID: NCT03006172
Study Description
Brief Summary: This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Massachusetts General Hospital., Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Philippe Bedard Clinic Toronto, Toronto, Ontario, Canada
Institut Bergonie, Bordeaux, , France
Institut Gustave Roussy, Villejuif, , France
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Barts and the London NHS Trust., London, , United Kingdom
Royal Marsden Hospital - London, London, , United Kingdom
Royal Marsden Hospital - Surrey, Surrey, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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