NCT03854227

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

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	PF-06939999 dose escalation	PF-06939999 orally at escalating doses on a continuous basis
DRUG	PF-06939999 monotherapy	PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
DRUG	PF-06939999 in combination with docetaxel	PF-06939999 orally on a continuous basis in combination with docetaxel

Timeline

• Start date: 2019-03-14
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2019-02-26
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study