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NCT01536743 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01536743 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 26 participants.
The verdict
NCT01536743, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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).
Interventions
- DRUG PD0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-12-15 |
| Est. Completion | 2020-02-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01536743
The ClinicalTrials.gov registry entry for NCT01536743 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PD0332991 is the first listed.
NCT01536743 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01536743 about?
NCT01536743 is a clinical study titled "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". 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 ...
What is the current status of trial NCT01536743?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2011-12-15. Estimated completion is 2020-02-24.
What interventions are being tested in trial NCT01536743?
The interventions under investigation include: PD0332991 (DRUG).
Who is sponsoring clinical trial NCT01536743?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
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