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NCT01281514 · ClinicalTrials.gov registry record · Phase 1
A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer
A Phase 1 study, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01281514: Completed Phase 1 study, sponsored by Fox Chase Cancer Center.
NCT01281514 is a Phase 1 study that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01281514, a Phase 1 study, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and PLD together with everolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with carboplatin and PLD in treating patients with relapsed ovarian epithelial, fallopian tube, or peritoneal cavity cancer
Primary Outcome
Determine the MTD of RAD001 (everolimus) in combination with carboplatin and pegylated liposomal doxorubicin. The MTD is defined as the dose level closest to, but not over that which is predicted to result in a DLT rate of 30%, the target toxicity.
Interventions
- OTHER laboratory biomarker analysis
- DRUG carboplatin
- DRUG pegylated liposomal doxorubicin hydrochloride
- DRUG everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-12-14 |
| Est. Completion | 2018-01-08 |
| Phase | Phase 1 |
What the finished NCT01281514 record still lists
NCT01281514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01281514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01281514 about?
NCT01281514 is a clinical study titled "A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer". RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some o...
What is the current status of trial NCT01281514?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-12-14. Estimated completion is 2018-01-08.
What interventions are being tested in trial NCT01281514?
The interventions under investigation include: laboratory biomarker analysis (OTHER), carboplatin (DRUG), pegylated liposomal doxorubicin hydrochloride (DRUG), everolimus (DRUG).
Who is sponsoring clinical trial NCT01281514?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01281514's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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