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PI3K Inhibitor
Inavolisib for Solid Cancers and Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants with locally advanced or metastatic PIK3CA-mutant HER2+ breast cancer (Stage II Arm G)
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 (Stages I and II)
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
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 belowSelect...
I am a woman with advanced breast cancer that is HER2 positive and has a PIK3CA mutation.
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I can provide a tissue sample from my cancer for testing.
Select...
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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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.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreTrial 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
Inavolisib
2021
Completed Phase 2
~260
Fulvestrant
2011
Completed Phase 3
~3690
Letrozole
2002
Completed Phase 4
~3240
Palbociclib
2017
Completed Phase 3
~3760
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,499 Total Patients Enrolled
96 Trials studying Breast Cancer
22,962 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,192 Total Patients Enrolled
137 Trials studying Breast Cancer
71,840 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated brain metastases.I have previously been treated with a CDK4/6 inhibitor.You are expected to live for at least 12 weeks.I am a woman with advanced breast cancer that is HER2 positive and has a PIK3CA mutation.I have a long QT syndrome or a family history of sudden death related to it.I can provide a tissue sample from my cancer for testing.I have symptoms from my lung disease.I had to stop taking an mTOR inhibitor due to severe side effects.My cancer is advanced, cannot be cured, and has a PIK3CA mutation.My breast cancer is of a rare type called metaplastic.I have had cancer spread to the lining of my brain and spinal cord.I do not have any serious infections needing IV antibiotics.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer in the last 5 years, except for certain skin, cervical, or early uterine cancers.You cannot or do not want to swallow pills.I am a postmenopausal woman with advanced breast cancer that is hormone receptor positive and HER2 negative.My heart pumps blood well (ejection fraction is 50% or more).I have received more than 360 mg/m2 of doxorubicin.I do not have uncontrolled high blood pressure or unstable chest pain.I am a woman with advanced breast cancer that is hormone receptor positive and HER2 negative.You are expected to live for at least 12 weeks.I have or had heart rhythm problems or heart failure needing medication.I have uncontrolled fluid buildup in my chest or abdomen.You have a disease that can be measured and evaluated according to specific medical guidelines.I take medication to manage my Type 1 or Type 2 diabetes.I do not have conditions that affect how my body absorbs food.I have a history of serious heart issues.I have had more than one chemotherapy treatment for my advanced cancer.I had severe side effects from trastuzumab or pertuzumab, leading to stopping the treatment.My heart's pumping ability decreased after taking trastuzumab.My blood, liver, and kidney functions are within normal ranges.I have previously been treated with a PI3K inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Stage I Arm A: Inavolisib Single Agent
- Group 2: Stage II Arm C: Inavolisib + Letrozole
- Group 3: Stage II Arm D: Inavolisib + Fulvestrant
- Group 4: Stage II Arm E: Inavolisib + Palbociclib + Fulvestrant
- Group 5: Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + Metformin
- Group 6: Stage II Arm G: Inavolisib + Trastuzumab + Pertuzumab
- Group 7: Stage I Arm B: Inavolisib + Palbociclib + Letrozole
- Group 8: Stage I Arm C: Inavolisib + Letrozole
- Group 9: Stage II Arm B: Inavolisib + Palbociclib + Letrozole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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