Trials / Completed
CompletedNCT01037790
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 304 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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. 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.
Conditions
- Adult Solid Tumor
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
- Adult Central Nervous System Germ Cell Tumor
- Adult Teratoma
- Benign Teratoma
- 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 Melanoma
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PD-0332991 | Given orally, 125 mg QD on a 21-day |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2009-12-23
- Last updated
- 2021-03-11
- Results posted
- 2021-03-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01037790. Inclusion in this directory is not an endorsement.