NCT03685591

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 06952229 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 dose escalation and expansion study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.

Detailed description

This is a Phase 1, open label, multi center, multiple dose, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06952229 in previously treated patients with advanced or metastatic cancers that may have high TGFbeta signatures and EMT expression. The study includes Parts 1A and 1B, which are dose-escalation for monotherapy and combination therapy with enzalutamide, respectively, and Parts 2A and 2B, which are dose expansion for monotherapy and combination therapy with enzalutamide, respectively.

Conditions

• Breast Neoplasms
• Prostate Neoplasms
• Neoplasms, Squamous Cell
• Melanoma
• Mesothelioma
• Pancreatic Neoplasms
• Colorectal Neoplasms
• Carcinoma, Renal Cell
• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	PF-06952229	Oral 7 days on / 7 days off - 28 day cycles (Part 1)
DRUG	Enzalutamide	Prostate Cancer (Part 2). 160mg, capsules, orally, daily

Timeline

• Start date: 2018-10-04
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2018-09-26
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study