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

Phase 1/2 Terminated 6 enrolled Arkadiusz Z. Dudek, MD Genentech, Inc. · collab HealthPartners Institute Regions Cancer Care Center · collab Midwest Melanoma Partnership · collab Vanquish Oncology, Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2021-01-11
Primary completion: 2022-03-22
Completion: 2022-06-24

Outcome

Outcome not reported

Stopped (Business): “This study required dose reductions to the lower dose level (Dose level -1). But this dose level (Dose level -1) was not further explored because of lack of funding.”

Publications

Boudreau MW, Tonogai EJ, Schane CP, Xi MX, Fischer JH, Vijayakumar J, Ji Y, Tarasow TM, Fan TM, Hergenrother PJ, Dudek AZ. The combination of PAC-1 and entrectinib for the treatment of metastatic uveal melanoma. Melanoma Res. 2023 Dec 1;33(6):514-524. doi: 10.1097/CMR.0000000000000927. Epub 2023 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Entrectinib	Small molecule	—	Oral
Subject	PAC-1	Small molecule	—	Oral