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PI3K Inhibitor

Inavolisib for Solid Cancers and Breast Cancer

Phase 1
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer (Stage I Arm A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to occurrence of complete response (cr) or partial response (pr) on 2 consecutive occasions >/=4 weeks apart (up to approximately 6 years)
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer drug, inavolisib, for safety and how well it works in patients with PIK3CA-mutant solid tumors. It will be given as a single agent or in combination with other standard-of-care cancer treatments.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including breast cancer, that have a specific mutation (PIK3CA). Participants must be in good physical condition (ECOG 0 or 1) and expected to live at least 12 weeks. Women with hormone receptor-positive/HER2-negative or HER2-positive breast cancer are eligible. Key exclusions include recent other cancers, significant heart conditions, uncontrolled illnesses, prior treatments with certain drugs, and inability to swallow pills.Check my eligibility
What is being tested?
The study tests the drug Inavolisib alone or combined with standard therapies for advanced breast cancer. It's an open-label Phase I trial with two stages: dose-escalation to find safe amounts of Inavolisib and expansion to see how well it works across seven different treatment combinations involving drugs like Palbociclib, Letrozole, Fulvestrant, Metformin, Trastuzumab and Pertuzumab.See study design
What are the potential side effects?
Possible side effects may include digestive issues; changes in blood counts affecting liver and kidney function; fatigue; reactions related to the heart such as irregular heartbeat; potential interactions leading to increased risk of infection due to immune system effects; skin reactions; and symptoms from nervous system involvement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced, cannot be cured, and has a PIK3CA mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a postmenopausal woman with advanced breast cancer that is hormone receptor positive and HER2 negative.
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My heart pumps blood well (ejection fraction is 50% or more).
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I am a woman with advanced breast cancer that is hormone receptor positive and HER2 negative.
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My blood, liver, and kidney functions are within normal ranges.
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I can provide a tissue sample from my cancer for testing.
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I am a woman with advanced breast cancer that is HER2 positive and has a PIK3CA mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to occurrence of complete response (cr) or partial response (pr) on 2 consecutive occasions >/=4 weeks apart (up to approximately 6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to occurrence of complete response (cr) or partial response (pr) on 2 consecutive occasions >/=4 weeks apart (up to approximately 6 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Adverse Events and Serious Adverse Events
Recommended Phase II Dose of Inavolisib
Stage 1: Percentage of Participants With Dose Limiting Toxicities
Secondary outcome measures
AUC from Time Zero to Dosing Interval (AUC0-tau) of Inavolisib
AUC of Fulvestrant
AUC of Letrozole
+20 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Stage II Arm G: Inavolisib + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
Participants will receive inavolisib in combination with trastuzumab and pertuzumab (Days 1-21). Dose of inavolisib will be determined from the results of Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group II: Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + MetforminExperimental Treatment4 Interventions
Participants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21), fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles) and metformin (Days 1-28)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group III: Stage II Arm E: Inavolisib + Palbociclib + FulvestrantExperimental Treatment3 Interventions
Participants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21) and fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group IV: Stage II Arm D: Inavolisib + FulvestrantExperimental Treatment2 Interventions
Participants will receive inavolisib on Days 1-28 in combination with fulvestrant on Day 1 and 15 of Cycle 1 and then on Day 1 from Cycle 2 (cycle length: 28 days). Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group V: Stage II Arm C: Inavolisib + LetrozoleExperimental Treatment2 Interventions
Participants will receive inavolisib in combination with letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group VI: Stage II Arm B: Inavolisib + Palbociclib + LetrozoleExperimental Treatment3 Interventions
Participants will receive inavolisib on Days 1-28 in combination with palbociclib on Days 1-21 and letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group VII: Stage I Arm C: Inavolisib + LetrozoleExperimental Treatment2 Interventions
Participants will receive inavolisib in escalating dose levels along with letrozole on Days 1-28 of each 28-day cycle. The starting dose of inavolisib will not exceed the starting dose in Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group VIII: Stage I Arm B: Inavolisib + Palbociclib + LetrozoleExperimental Treatment3 Interventions
Participants will receive inavolisib in escalating dose levels (starting dose 3 mg) on Days 1-28, palbociclib on Days 1-21, and letrozole on Days 1-28 of each 28-day cycle. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Group IX: Stage I Arm A: Inavolisib Single AgentExperimental Treatment1 Intervention
Participants will receive inavolisib in escalating dose levels with starting dose of 6 milligrams (mg). Participants will receive single dose of inavolisib on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Fulvestrant
2011
Completed Phase 3
~3700
Letrozole
2002
Completed Phase 4
~3240
Palbociclib
2017
Completed Phase 3
~3720
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,609 Total Patients Enrolled
96 Trials studying Breast Cancer
22,962 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,465 Total Patients Enrolled
137 Trials studying Breast Cancer
71,841 Patients Enrolled for Breast Cancer

Media Library

Inavolisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03006172 — Phase 1
Breast Cancer Research Study Groups: Stage II Arm E: Inavolisib + Palbociclib + Fulvestrant, Stage II Arm G: Inavolisib + Trastuzumab + Pertuzumab, Stage II Arm D: Inavolisib + Fulvestrant, Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + Metformin, Stage II Arm C: Inavolisib + Letrozole, Stage I Arm A: Inavolisib Single Agent, Stage I Arm B: Inavolisib + Palbociclib + Letrozole, Stage I Arm C: Inavolisib + Letrozole, Stage II Arm B: Inavolisib + Palbociclib + Letrozole
Breast Cancer Clinical Trial 2023: Inavolisib Highlights & Side Effects. Trial Name: NCT03006172 — Phase 1
Inavolisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03006172 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~24 spots leftby Nov 2024