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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 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 28 participants.
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.
Interventions
- DRUG Paclitaxel
- DRUG PD0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-03 |
| Est. Completion | 2019-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01320592
The ClinicalTrials.gov registry entry for NCT01320592 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01320592 reports 0 study locations.
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.
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