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
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
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.
Letrozole: Participants will receive once daily oral doses of letrozole 2.5 mg on Days 1-28 of each cycle.
Palbociclib: Participants will receive once daily oral doses of palbociclib 125 mg on Days 1-21 of each cycle.
Metformin: Participants will receive oral metformin once daily, starting on Cycle 1, Day 1, as tolerated.
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.
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.
Study 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)).
Eligibility
Primary outcome measure(s)
- Stage 1: Percentage of Participants With Dose Limiting Toxicities — Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35)
- Recommended Phase II Dose of Inavolisib — Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35)
- Percentage of Participants With Adverse Events and Serious Adverse Events — Day 1 up to 6 years
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital. | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Columbia University Medical Center | New York | New York | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| Princess Margaret Hospital | Toronto | Ontario | |
| Institut Bergonie | Bordeaux | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | |
| Royal Marsden Hospital - Surrey | Surrey | Sutton | |
| St Bartholomew's Hospital | London | United Kingdom |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03006172 on ClinicalTrials.gov ↗ ← All trials in the USA