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NCT01320592 · ClinicalTrials.gov registry record · Phase 1
PD0332991/Paclitaxel in Advanced Breast Cancer
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01320592: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01320592 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320592, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are anticipated to be enrolled to reach the Maximum Tolerated Dose (MTD) of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to establish the Recommended Phase 2 Dose (RP2D), obtain additional safety data and perform exploratory biomarker studies.
Primary Outcome
To determine the maximally-tolerated dose and safety of PD0332991 in combination with a fixed, weekly dose of Paclitaxel of 80 mg/m2 and to characterize the safety of the combination during the first three cycles of therapy.
Interventions
- DRUG Paclitaxel
- DRUG PD0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-03 |
| Est. Completion | 2019-05 |
| Phase | Phase 1 |
What the finished NCT01320592 record still lists
NCT01320592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01320592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01320592 about?
NCT01320592 is a clinical study titled "PD0332991/Paclitaxel in Advanced Breast Cancer". This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are anticipated to be enrolled to reach the Maximum Tolerated Dose (MTD) of PD0332991 in combination with Paclitaxel. Once the ...
What is the current status of trial NCT01320592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-03. Estimated completion is 2019-05.
What interventions are being tested in trial NCT01320592?
The interventions under investigation include: Paclitaxel (DRUG), PD0332991 (DRUG).
Who is sponsoring clinical trial NCT01320592?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01320592's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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