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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: Completed Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT01536743 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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 |
What the finished NCT01536743 record still lists
NCT01536743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which PD0332991 is the first listed.
NCT01536743 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01536743's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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