PD 0332991 in Treating Patients With Refractory Solid Tumors
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.
Adult Solid Tumor
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Adult Central Nervous System Germ Cell Tumor
Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
Familial Testicular Germ Cell Tumor
HER2-negative Breast Cancer
HER2-positive Breast Cancer
Male Breast Cancer
Ovarian Immature Teratoma
Ovarian Mature Teratoma
Ovarian Monodermal and Highly Specialized Teratoma
Progesterone Receptor-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Recurrent Breast Cancer
Recurrent Colon Cancer
Recurrent Extragonadal Germ Cell Tumor
Recurrent Extragonadal Non-seminomatous Germ Cell Tumor
Recurrent Extragonadal Seminoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Recurrent Rectal Cancer
Stage III Extragonadal Non-seminomatous Germ Cell Tumor
Stage III Extragonadal Seminoma
Stage III Malignant Testicular Germ Cell Tumor
Stage III Ovarian Germ Cell Tumor
Stage IV Breast Cancer
Stage IV Colon Cancer
Stage IV Extragonadal Non-seminomatous Germ Cell Tumor
Stage IV Extragonadal Seminoma
Stage IV Melanoma
Stage IV Ovarian Germ Cell Tumor
Stage IV Rectal Cancer
Testicular Immature Teratoma
Testicular Mature Teratoma
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer|
- Response rates [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Pharmacodynamic effects on tumor and non-tumor tissue [ Designated as safety issue: No ]
- Relationship between selected biomarkers, pharmacokinetics, and/or efficacy and safety outcomes [ Designated as safety issue: No ]
- Population pharmacokinetic for PD 0332991 and correlation with efficacy outcomes [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral PD 0332991 once daily on days 1-21.
Given orallyOther: pharmacological study
Other Name: pharmacological studies
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037790
|Contact: Peter O Dwyer, MD||855-216-0098||PennCancerTrials@emergingmed.com|
|United States, Pennsylvania|
|Abramson Cancer Center of The University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Peter ODwyer 855-216-0098 PennCancerTrials@emergingmed.com|
|Principal Investigator: Peter ODwyer|
|Principal Investigator:||Peter ODwyer||Abramson Cancer Center of the University of Pennsylvania|