NCT04589832

Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma

Phase 1B/2 Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Arkadiusz Z. Dudek, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single arm study with dose escalation Phase Ib cohort followed by a Phase II cohort. PAC-1 (PO) will be given daily on Days 1 through 21 of each cycle (28-day cycle). Entrectinib (PO) will be given daily on Days 1 through 28 of each cycle. Response will be evaluated after every 2 cycles. Treatment will continue until disease progression based on RECIST criteria or intolerable toxicity.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	PAC-1	Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
DRUG	Entrectinib	Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-03-22
• Completion: 2022-06-24
• First posted: 2020-10-19
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study