What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine combined with nab-paclitaxel, often result in side effects like neutropenia, fatigue, neuropathy, and diarrhea. Targeted therapies, including KRAS G12C inhibitors like Adagrasib, are being studied for their efficacy and safety, but specific side effects for Adagrasib are not detailed in the provided context. Generally, targeted therapies can cause gastrointestinal issues, fatigue, and potential liver toxicity. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including traditional chemotherapies like gemcitabine and nab-paclitaxel, as well as targeted therapies. For instance, Olaparib, a PARP inhibitor, has been approved for patients with germline BRCA-mutated metastatic pancreatic cancer. While specific KRAS G12C inhibitors like Adagrasib are still under investigation, the approval of other targeted therapies highlights the ongoing efforts to develop precision medicine approaches for pancreatic cancer.

What other types of research exist?

Promising alternatives to Adagrasib for pancreatic cancer patients include: 1) Olaparib for patients with germline BRCA mutations, 2) Futibatinib for patients with FGFR2 fusions/rearrangements, and 3) Pembrolizumab for patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These therapies target specific genetic alterations and have shown efficacy in clinical trials.

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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

Must not have

Known active human immunodeficiency virus (HIV) or Hepatitis B or C

Inability to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Adagrasib, a new drug, to see if it can help control pancreatic cancer in patients with a specific genetic mutation (KRAS G12C). The drug works by blocking this mutation to stop the cancer from growing.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active HIV, Hepatitis B, or Hepatitis C infection.

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I cannot swallow pills.

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I have active cancer spread to my brain.

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I have another cancer that needs treatment or could affect the study of my pancreatic cancer.

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I have not had major surgery in the last 4 weeks.

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I have heart problems.

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I have cancer cells in the fluid around my brain and spinal cord.

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I have had severe bleeding or coughed up blood, causing my hemoglobin to drop below 8 g/dL recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include gemcitabine, S-1, and KRAS G12C inhibitors like adagrasib. Gemcitabine is a nucleoside analog that inhibits DNA synthesis, leading to cell death, and is often used as a first-line treatment. S-1 is an oral fluoropyrimidine that combines three agents to inhibit DNA synthesis and reduce treatment-related side effects. KRAS G12C inhibitors, such as adagrasib, specifically target the KRAS G12C mutation, which is present in a small subset of pancreatic cancers, by inhibiting the mutant KRAS protein's function, thereby blocking cancer cell growth. Understanding these mechanisms is crucial for pancreatic cancer patients as it helps tailor treatments based on the tumor's genetic profile, potentially improving outcomes and minimizing unnecessary side effects.