MedTrace Logo

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

NCT01037790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2021-03-11

Study results available
· View outcomes & findings →

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.

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

DRUG

PD-0332991

Given orally, 125 mg QD on a 21-day

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Peter ODwyer · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037790 on ClinicalTrials.gov