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Kinase Inhibitor

Monotherapy Cohort 1 (binimetinib) for Pancreatic Cancer

Phase 2

Recruiting

Led By Geoffrey I Shapiro

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Histologically confirmed cancer for each cohort for which curable treatment modalities are not an option

COHORT 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests a combination of drugs to see if they can help improve outcomes in certain cancers. The drugs work by blocking proteins that signal cancer cells to multiply.

Who is the study for?

This trial is for patients with RAS-mutated cancers, such as low grade serous ovarian cancer and pancreatic cancer, who have no curable treatment options. Participants must have measurable disease, be able to undergo a biopsy, and not have had prior MEK inhibitor or CDK4/6 inhibitor therapy (with exceptions for certain mutations). They should also meet all ComboMATCH Registration Protocol criteria.Check my eligibility

What is being tested?

The effectiveness of combining two kinase inhibitors, palbociclib and binimetinib, is being tested in this phase II trial. The study aims to see if this drug combo can delay cancer growth in patients with specific tumor DNA changes and improve survival without progression in various cancers excluding lung, colon cancer, melanoma.See study design

What are the potential side effects?

Palbociclib and Binimetinib may cause side effects like fatigue, nausea, diarrhea, hair loss (alopecia), rash or itching skin (dermatitis), liver issues (hepatotoxicity), blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer cannot be cured with surgery or other common treatments.

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I have not taken MEK inhibitor or CDK4/6 inhibitor drugs before.

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I meet all requirements of the ComboMATCH study and have submitted my genetic testing data.

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My cancer has specific genetic changes in KRAS, NRAS, HRAS, or BRAF.

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I have low grade serous ovarian cancer with a specific genetic mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

ORR (Cohort 3)

ORR (Cohort 4)

Objective response rate (ORR) (Cohort 2)

+1 more

Secondary outcome measures

Disease control (All Cohorts)

Duration of response (DoR) (All Cohorts)

Incidence of adverse events (AE) (All Cohorts)

+3 more

Other outcome measures

Changes in plasma RAS allelic burden in KRAS-mutated tumors (Cohorts 1 and 2)

Determinants of response (Cohorts 3 and4)

Determinants of response and resistance (Cohorts 1 and 2)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy Cohort 1 (binimetinib)Experimental Treatment6 Interventions

Patients receive binimetinib PO BID daily, in the absence of disease progression or unacceptable toxicity, for up to 3 years. Patients who experience disease progression may elect to migrate to the combination cohort. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Group II: Combination Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)Experimental Treatment7 Interventions

Patients receive palbociclib PO QD on days 1-21 and binimetinib PO BID on days 1-28 of each cycle. throughout the trial. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 3 years. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Palbociclib

2017

Completed Phase 3

~3760

Binimetinib

2018

Completed Phase 3

~1100

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,242 Total Patients Enrolled

Geoffrey I ShapiroPrincipal InvestigatorAlliance for Clinical Trials in Oncology

3 Previous Clinical Trials

148 Total Patients Enrolled

Frequently Asked Questions

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

How many participants have contributed to this research endeavor?

"Affirmative. The clinicaltrials.gov listing shows that this medical trial has been continually recruiting since its initial posting on August 11th 2024 and was last updated December 6th 2023. This study requires 199 patients to be enrolled from 18 different sites."

Answered by AI

How expansive is the geographical reach of this trial?

"This clinical trial includes enrollees from 18 separate medical centres, including Saint Joseph Mercy Hospital in Ann Arbor, Genesee Hematology Oncology PC in Flint and Kootenai Clinic Cancer Services - Post Fallsin Post Falls."

Answered by AI

Is enrollment still available for this clinical trial?

"Yes, according to clinicaltrials.gov there is a demand for patients in this medical study. The trial was initially posted on August 11th 2024 and the most recent update occurred on December 6th 2023. This program seeks 199 participants over 18 sites."

Answered by AI

Has the federal government sanctioned binimetinib as part of a monotherapy cohort?

"Our team at Power have rated the safety of Monotherapy Cohort 1 (binimetinib) as a 2. This is because, while there is some evidence suggesting its safety, no data exists to support efficacy in a Phase 2 trial setting."

Answered by AI

What is the projected outcome of this medical trial?

"This clinical trial will measure its primary outcome, overall response rate (Cohort 3), within a period of up to three years. Secondary outcomes include the study's Overall Survival (OS) which is calculated by evaluating if patients are alive at their last follow-up and censoring them accordingly; Progression Free Survival (PFS) assessed using RECIST 1.1 criteria for disease rampancy; and Duration of Response time from when objective status was first noted as either CR or PR until progression or death occurred. Kaplan Meier methods will be utilized to estimate distribution in all cases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

2023. "Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554367.

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