← Back to Search

Kinase Inhibitor

Palbociclib + 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

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ORR (Cohort 3)

ORR (Cohort 4)

Objective response rate (ORR) (Cohort 2)

+1 more

Secondary study objectives

Disease control (All Cohorts)

Duration of response (DoR) (All Cohorts)

Incidence of adverse events (AE) (All Cohorts)

+3 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180