At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 304 enrolled
Drug / intervention
PD-0332991drug
Likely dose
PD-0332991 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
In Brief
A Phase 2 clinical trial evaluating PD-0332991 for Adult Solid Tumor and 38 related conditions. Completed, enrolled 304 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult 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
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedDec 2009
Primary CompletionOct 2019
TodayJul 2026
First PostedDec 23, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 16.5 years ago
Interventions
PD-0332991drug
Given orally, 125 mg QD on a 21-day