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KRASG12C Inhibitor

Adagrasib for Pancreatic Cancer

Phase 1
Recruiting
Led By Dan Zhao, 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
No more than one prior therapy
Unresectable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Study Summary

This trial investigates if a drug, adagrasib, can help control pancreatic cancer caused by a KRAS G12 mutation. Safety and effects are studied too.

Who is the study for?
This trial is for adults with metastatic pancreatic cancer that has a specific mutation called KRAS G12C. Participants can have had only one prior therapy and must have recovered from its side effects. They should be in relatively good health (ECOG 0-2), not pregnant, willing to use contraception, and able to follow the study's procedures.Check my eligibility
What is being tested?
The focus of this trial is on adagrasib (MRTX849), an investigational drug targeting the KRAS G12C mutation in pancreatic cancer. The goal is to see if it can control the disease and assess its safety profile.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for drugs like adagrasib may include nausea, diarrhea, fatigue, liver issues, and potential allergic reactions. Each person's experience with side effects may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had only one previous treatment.
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My cancer cannot be removed by surgery or has spread to other parts of my body.
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My pancreatic cancer has a specific KRAS G12C mutation.
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I have recovered from previous treatment side effects, except for hair loss and nerve issues.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer cannot be removed by surgery or has spread.
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I have recovered from previous treatment side effects, except for hair loss and nerve issues.
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I am 18 years old or older.
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My pancreatic cancer has a KRAS G12C mutation.

Timeline

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
Overall survival (OS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MRTX849 (Adagrasib)Experimental Treatment1 Intervention
Helps to control pancreatic cancer that has a KRAS G12 mutation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,376 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,191 Total Patients Enrolled
Dan Zhao, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Adagrasib (MRTX849) (KRASG12C Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05634525 — Phase 1
Pancreatic Cancer Research Study Groups: MRTX849 (Adagrasib)
Pancreatic Cancer Clinical Trial 2023: Adagrasib (MRTX849) Highlights & Side Effects. Trial Name: NCT05634525 — Phase 1
Adagrasib (MRTX849) (KRASG12C Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05634525 — Phase 1
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT05634525 — Phase 1

Frequently Asked Questions

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

Is there still capacity to enroll participants in this trial?

"Clinicaltrials.gov confirms this medical trial is not presently recruiting patients; it was initially posted on March 31st 2023 and last modified November 22nd 2022. Nonetheless, 585 other trials are actively looking for participants at the moment."

Answered by AI

Has the FDA given authorization for MRTX849 (Adagrasib) to be used by healthcare professionals?

"The safety of MRTX849 (Adagrasib) was assessed as a 1 due to its status in Phase 1 clinical trials, which indicates that there is limited evidence and data supporting the efficacy and security of this drug."

Answered by AI

Who else is applying?

What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

The patient was featured g12c mutation and are expericing the AG chemotherapy. we are finding next effective way to laxation the disease.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. M D Anderson Cancer Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients
2023. "Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05634525.
~9 spots leftby Nov 2027
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