Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Pancreatic Cancer
- Tumor, Solid
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a standard 3+3 dose escalation design.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
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. Up to a maximum of 30 adult patients will be enrolled in the 5 possible dose esc...
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. Up to a maximum of 30 adult patients will be enrolled in the 5 possible dose escalation cohorts. These patients will have histologically confirmed advanced solid tumor disease refractory to standard of care therapy, or for which there is no accepted standard of care. Finally, 15 adult patients will be treated at the recommended phase II dose (RP2D) in the expansion cohort involving metastatic pancreatic cancer patients who have received at least one line of therapy in the metastatic setting.
Tracking Information
- NCT #
- NCT03454035
- Collaborators
- BioMed Valley Discoveries, Inc
- Pfizer
- Investigators
- Principal Investigator: Autumn McRee, MD University of North Carolina, Chapel Hill
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