To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Particip… (NCT03006172) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States, Canada, France200 participantsStarted 2016-12-13
Plain-language 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)).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Evaluable or measurable disease per RECIST, Version 1.1 (measurable disease only for Arm D)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of greater than or equal to (\>=) 12 weeks
* Adequate hematologic and organ function, including blood counts, liver and kidney function
Stage I Arm A (Inavolisib):
\- Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer
Stages I and II, Arms B and C:
\- Postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer
Stage II, Arms D, E, or F:
\- Female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer
Stage II Arm D:
\- Prior treatment with CDK4/6 inhibitor
Stage II Arm G:
* Female participants with locally advanced or metastatic PIK3CA-mutant HER2+ breast cancer
* Left ventricular ejection fraction 50% or greater
Stages I and II:
\- All participants must provide tumor tissue from the primary or metastatic tumor site obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA mutation by central laboratory test.
Exclusion Criteria:
* Metaplastic breast cancer
* History of leptomeningeal disease
* Type 1 or 2 diabetes requiring anti-hyperglycemic medication
* Inability or unwillingness to swallow pills
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Know…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to find a safe dose of inavolisib and measure side effects rather than to prove it works, what does that mean for my personal benefit-to-risk balance compared to sticking with standard treatment options?
2The trial is listed as 'active, not recruiting' — does that mean new patients can no longer join, and if so, are there any similar or follow-on studies using inavolisib that I might actually be eligible for?
3Because one of the main things being measured is dose-limiting toxicities and serious adverse events, what kinds of side effects have been observed so far in participants taking inavolisib, and how would those affect my day-to-day life?
4This trial tests inavolisib both as a single agent and in combination with endocrine and targeted therapies for breast cancer — given my specific diagnosis and any treatments I've already had, which of those approaches would be most relevant to my situation?
5Are there approved or standard-of-care therapies that target the same pathway as inavolisib that I should consider first, before looking at a Phase 1 study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stage 1: Percentage of Participants With Dose Limiting Toxicities
Timeframe: Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35)
2
Recommended Phase II Dose of Inavolisib
Timeframe: Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35)
3
Percentage of Participants With Adverse Events and Serious Adverse Events