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A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

NCT01227434 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-07-17

Study results available
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Summary

This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as measured by progression free survival at 6 months) in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15 will undergo a planned surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery, and the other 15 patients will receive drug without a planned surgical procedure.

Conditions

Interventions

DRUG

PD 0332991 (pre-surgery)

PD 0332991 for 7 days prior to an indicated, intended surgical resection for progression

DRUG

PD 0332991

PD 0332991 daily for 21 consecutive days followed by a 7 day break off therapy, repeating cycles

PROCEDURE

Resection as clinical care

Indicated, intended, surgical resection as clinical care

Sponsors & Collaborators

Principal Investigators

  • Michael D Prados, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01227434 on ClinicalTrials.gov