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NCT02599363 · ClinicalTrials.gov registry record · Phase 1
A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02599363: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT02599363 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02599363, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a Phase I study to assess the safety and Maximum tolerated dose (MTD) of paclitaxel + ribociclib (LEE011) in patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3 + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose escalation proceeds in 200 mg increments up to a maximum of 600 mg. Dose-limiting toxicities (DLT) will be based upon first-cycle toxicity.
Interventions
- DRUG Paclitaxel
- DRUG Ribociclib (LEE011)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-03-12 |
| Phase | Phase 1 |
What the finished NCT02599363 record still lists
NCT02599363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT02599363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02599363 about?
NCT02599363 is a clinical study titled "A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer". This is a Phase I study to assess the safety and Maximum tolerated dose (MTD) of paclitaxel + ribociclib (LEE011) in patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3 + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose ...
What is the current status of trial NCT02599363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-01. Estimated completion is 2019-03-12.
What interventions are being tested in trial NCT02599363?
The interventions under investigation include: Paclitaxel (DRUG), Ribociclib (LEE011) (DRUG).
Who is sponsoring clinical trial NCT02599363?
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 NCT02599363's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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