A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Ovarian Epithelial Carcinoma Clinical Trial

Official title:
A Open Label Phase II Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Status Completed

Clinical Trial Summary

The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01536743
Study type	Interventional
Source	Jonsson Comprehensive Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	December 15, 2011
Completion date	February 24, 2020

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See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05856643` - Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma	Early Phase 1
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Recruiting	`NCT04794322` - Developing a Test for the Detection of Ovarian Cancer