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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 13, 2016

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast CancerSolid Tumor
Interventions
DRUG

Inavolisib

Participants will receive oral inavolisib once daily on Days 1-28 of each 28-day cycle (Arms A, B, C, D, E, F) or Days 1-21 of each 21-day cycle (Arm G).

DRUG

Fulvestrant

Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1 and 15 of Cycle 1. For subsequent cycles, participants will receive fulvestrant intramuscularly on Day 1 of each cycle.

DRUG

Letrozole

Participants will receive once daily oral doses of letrozole 2.5 mg on Days 1-28 of each cycle.

DRUG

Palbociclib

Participants will receive once daily oral doses of palbociclib 125 mg on Days 1-21 of each cycle.

DRUG

Metformin

Participants will receive oral metformin once daily, starting on Cycle 1, Day 1, as tolerated.

DRUG

Trastuzumab

Participants will receive trastuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles, until disease progression or unacceptable toxicity.

DRUG

Pertuzumab

Participants will receive pertuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 840 mg for Cycle 1 and a dose of 420 mg for subsequent cycles, until disease progression or unacceptable toxicity.

Trial Locations (10)

10032

Columbia University Medical Center, New York

33076

Institut Bergonie, Bordeaux

37203

SCRI Oncology Partners, Nashville

94805

Institut Gustave Roussy, Villejuif

02215

Dana Farber Cancer Institute, Boston

M5G2M9

Princess Margaret Hospital, Toronto

08035

Hospital Universitari Vall d'Hebron, Barcelona

SM2 5PT

Royal Marsden Hospital - Surrey, Surrey

EC1 A7BE

St Bartholomew's Hospital, London

SW3 6JJ

Royal Marsden Hospital - London, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY