A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

Phase 1 Terminated 54 enrolled Pfizer

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

Timeline

Start: 2019-03-14
Primary completion: 2022-04-27
Completion: 2022-04-27

Outcome

Outcome not reported

Stopped (Business): “The study has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.”

Publications

Guo C, Liao KH, Li M, Wang IM, Shaik N, Yin D. PK/PD model-informed dose selection for oncology phase I expansion: Case study based on PF-06939999, a PRMT5 inhibitor. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1619-1625. doi: 10.1002/psp4.12882. Epub 2022 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06939999	Small molecule	0.5 mg	Oral
Subject	PF-06939999	Small molecule	1 mg	Oral
Subject	PF-06939999	Small molecule	2 mg	Oral
Subject	PF-06939999	Small molecule	4 mg	Oral
Subject	PF-06939999	Small molecule	6 mg	Oral
Subject	PF-06939999	Small molecule	8 mg	Oral