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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03454035
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ulixertinib — DRUG
    Ulixertinib 300mg, orally, twice a day concomitantly with palbociclib
  • Palbociclib — DRUG
    Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib

Study Details

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.

Key Dates

Start date
Jan 30, 2018
Status verified
Sep 2025
Primary completion
Jul 15, 2026
Completion
Nov 24, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label, single arm Phase I
    Ulixertinib added to palbociclib

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Five weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Melissa Flores
[email protected]
Stergios Moschos
(866) 869-1856
Stergios Moschos, MD (PRINCIPAL_INVESTIGATOR)

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By condition
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By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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