RecruitingPhase 1NCT03454035

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

45 participants

Start Date

Jan 30, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two targeted drugs — ulixertinib and palbociclib — to see if they can slow or stop the growth of advanced cancers, including pancreatic cancer and melanoma that have stopped responding to other treatments. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor that no longer responds to standard treatment - For the expanded group: you have metastatic pancreatic cancer or advanced melanoma that has already received at least one prior treatment - For melanoma specifically: your tumor has certain genetic mutations (in NRAS, KRAS, HRAS, or NF1 genes) and your cancer progressed after immune checkpoint therapy - You are well enough to perform basic daily activities (not bedridden) - Your life expectancy is at least 3 months - Your liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to your brain or spinal cord (unless stable) - You have serious heart problems, including a history of heart attacks or a dangerously irregular heartbeat - You are pregnant or breastfeeding - Your organ function (liver, kidney, bone marrow) is significantly impaired - You have had certain recent infections or uncontrolled illnesses Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGUlixertinib

Ulixertinib 300mg, orally, twice a day concomitantly with palbociclib

DRUGPalbociclib

Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib


Locations(1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT03454035


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