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NCT02494921 · ClinicalTrials.gov registry record · Phase 1
LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC
A Phase 1 study, sponsored by Rahul Aggarwal.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02494921 is a Phase 1 study that has completed, run by Rahul Aggarwal. The registered enrollment target is 43 participants.
The verdict
NCT02494921, a Phase 1 study, has completed, sponsored by Rahul Aggarwal.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immedi
Interventions
- DRUG Prednisone
- DRUG Ribociclib
- DRUG Filgrastim
- DRUG Docetaxel-PNP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-11-20 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02494921
The ClinicalTrials.gov registry entry for NCT02494921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rahul Aggarwal, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT02494921 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02494921 about?
NCT02494921 is a clinical study titled "LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC". This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone ...
What is the current status of trial NCT02494921?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-11-20. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT02494921?
The interventions under investigation include: Prednisone (DRUG), Ribociclib (DRUG), Filgrastim (DRUG), Docetaxel-PNP (DRUG).
Who is sponsoring clinical trial NCT02494921?
This trial is sponsored by Rahul Aggarwal, which has 13 total clinical trials registered on ClinicalTrials.gov.
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