Spots Global Cancer Trial Database for Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

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Trial Identification

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

Official Title: 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

Study ID: NCT03454035

Conditions

Tumor, Solid

Pancreatic Cancer

Melanoma

Interventions

Ulixertinib

Palbociclib

Study Description

Brief 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.

Detailed 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 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. An expansion cohort enrollment will start After RP2D of ulixertinib combined with palbociclib is defined. Then 15 patients with metastatic pancreatic cancer and 15 patients with RAS-mutant melanoma will be enrolled. Note:Pancreatic cancer expansion cohort and all solid tumor cohorts are closed to enrollment.