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

NCT03454035 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ulixertinib

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

DRUG

Palbociclib

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

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Stergios Moschos, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2026-07-15
Completion
2026-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03454035 on ClinicalTrials.gov