Clinical Trial: PHASE II TRIAL OF THE CYCLIN-DEPEDENT KINASE INHIBITOR PD 0332991 IN PATIENTS WITH CANCER

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

Brief Summary:

RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.


Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the response rates following treatment with PD 0332991 in the following malignancies: 1) Metastatic breast cancer, 2) Metastatic colorectal cancer, 3) Metastatic melanoma with CDK4 mutation or amplification, or 4) Cisplatin-refractory, unresectable germ cell tumors.

II. To evaluate the safety and tolerability of PD 0332991 administered to subjects with refractory solid tumors.

SECONDARY OBJECTIVES:

I. To assess the pharmacodynamic effects of PD0332991 on tumor and non-tumor tissue.

II. To investigate the relationship between selected biomarkers, PK and/or efficacy and safety outcomes.

III. To estimate the population pharmacokinetic for PD 0332991 and to correlate PK with efficacy outcomes.

IV: To perform a Phase II evaluation of PD 0332991 in a population defined as potential responders on the basis of CCND1 gene amplification.

OUTLINE:

Patients receive oral PD 0332991 once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.


Sponsor: Abramson Cancer Center of the University of Pennsylvania

Current Primary Outcome:

  • Response rates [ Time Frame: 5 years ]
  • Safety and tolerability [ Time Frame: 5 years ]


Original Primary Outcome:

  • Response rates
  • Safety and tolerability


Current Secondary Outcome:

  • Pharmacodynamic effects on tumor and non-tumor tissue [ Time Frame: 5 years ]
  • Relationship between selected biomarkers, pharmacokinetics, and/or efficacy and safety outcomes [ Time Frame: 5 years ]
  • Population pharmacokinetic for PD 0332991 and correlation with efficacy outcomes [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Pharmacodynamic effects on tumor and non-tumor tissue
  • Relationship between selected biomarkers, pharmacokinetics, and/or efficacy and safety outcomes
  • Population pharmacokinetic for PD 0332991 and correlation with efficacy outcomes


Information By: Abramson Cancer Center of the University of Pennsylvania

Dates:
Date Received: December 10, 2009
Date Started: October 2009
Date Completion:
Last Updated: August 24, 2016
Last Verified: July 2016