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Protocol # 19-427

Status

Recruiting

Description

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

Condition

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

Interventions

  • PF-06952229
  • Enzalutamide

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Percentage of patients with dose limiting toxicities (Parts 1A, 1B)
  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (Parts 1A, 1B, 2A, 2B)
  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1A, 1B, 2A, 2B)
  • Percentage of Participants With PSA50 Response (Parts 2A, 2B)
  • Number of Participants With Tumor Reponse per PCWG2 and RECIST v1.1 (Parts 2A, 2B)

Secondary Outcome:

  • Parmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) - Part 1A, Part 2A
  • Parmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) - Part 1B, Part 2B
  • Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1A, Part 2A
  • Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1B, Part 2B
  • Pharmacokinetic Parameters: Area Under the Curve (AUC) - Part 1A, Part 2A
  • Pharmacokinetic Parameters: Area Under the Curve (AUC) - Part 1B, Part 2B
  • Pharmackinetic Parameters: Apparent Oral Clearance (CL/F) - Part 1A, Part 2A
  • Pharmackinetic Parameters: Apparent Oral Clearance (CL/F) - Part 1B, Part 2B
  • Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F) - Part 1A, Part 2A
  • Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F) - Part 1B, Part 2B
  • Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2) - Part 1A, Part 2A
  • Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2) - Part 1B, Part 2B
  • Percentage of Participants With PSA50 Response (Parts 1A, 1B)
  • Number of Participants With Tumor Reponse per PCWG2 and RECIST v1.1 (Parts 1A, 1B)
  • Objective Response Rate (ORR) (Parts 2A, 2B)
  • Duration of Response (DOR) (Parts 2A, 2B)
  • Progression free survival (PFS) (Parts 2A, 2B)
  • Overall Survival (OS) (Parts 2A, 2B)
  • Time to Progression (TTP) (Parts 2A, 2B)
  • Time to Response (TTR) (Parts 2A, 2B)
  • Median Intra-Tumor T cells (Parts 2A, 2B)

Enrollment

90

Study Start Date

October 4, 2018

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Pfizer

Source

Pfizer

Official title

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

Clinicaltrials.gov Identifier

NCT03685591

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.