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KRAS G12C Inhibitor

Adagrasib + Olaparib for Solid Tumors

Phase 1

Recruiting

Led By Timothy Yap, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women and men, who are sexually active and of childbearing potential, must agree to use two highly effective forms of contraception prior to study entry, for the duration of study participation, and for 6 months following termination of the study treatment

Histologically confirmed diagnosis of a solid tumor malignancy with a KRAS G12C mutation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a drug combo in people with advanced solid tumors and certain gene mutations.

Who is the study for?

Adults with advanced solid tumors that have specific mutations (KRAS G12C or KEAP1) can join this trial. They should be in good physical condition, not have major health issues that could affect the study, and agree to use effective contraception. People with certain gastrointestinal conditions, uncontrolled infections, recent significant bleeding or surgery, or those on strong CYP3A inhibitors/inducers are excluded.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs: Adagrasib and Olaparib for patients with certain genetic mutations in their tumors. The goal is to find the safest dose level. Participants will receive both medications and be monitored for how well they tolerate them and any signs of tumor response.See study design

What are the potential side effects?

Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk or bruising, shortness of breath, allergic reactions to medication components, liver function changes which may cause yellowing skin or eyesight problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use two effective birth control methods during and 6 months after the study.

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My cancer has a specific KRAS G12C 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 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adagrasib+OlaparibExperimental Treatment2 Interventions

Participants will take adagrasib and olaparib by mouth 2 times each day. Each dose should be taken at about 12 hours apart (1 dose in the morning, 1 dose in the evening). The study drugs should be swallowed whole with water. Do not chew, crush, dissolve, or divide the study drugs. If forget a dose and less than 2 hours have passed since the usual time participants take the study drug, take the dose as soon as participants remember. If more than 2 hours have passed, do not take the dose. Wait and take the next dose as scheduled

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adagrasib

2023

Completed Phase 1

~20

Olaparib

2007

Completed Phase 4

~2140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,449 Total Patients Enrolled

Mirati Therapeutics Inc.Industry Sponsor

70 Previous Clinical Trials

8,153 Total Patients Enrolled

Timothy Yap, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

7 Total Patients Enrolled

Frequently Asked Questions

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

Has the combination of Adagrasib and Olaparib achieved regulatory approval?

"Given that this is a Phase 1 trial, and thus has minimal data on efficacy and safety, our team at Power assigned Adagrasib+Olaparib to the lowest safety rating of 1."

Answered by AI

Are there currently opportunities to join this clinical experiment?

"According to clinicialtrials.gov, this medical trial is no longer seeking participants as the last update was made on 11/8/2023 and it was first posted on 5/31/2024. Nonetheless, there are still 2,621 other active studies searching for volunteers at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers

2024. "Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130254.