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NCT02985125 · ClinicalTrials.gov registry record · Phase 1
LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Georgetown University.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT02985125: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Georgetown University.
NCT02985125 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 44 participants, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02985125, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Georgetown University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
Primary Outcome
Determine the Recommended Phase II dose (RP2D) of LEE011 (ribociclib) in the combination with everolimus in patients with mPAC refractory to 5-FU- and GEM-based chemotherapy based on DLTs within the first 4 weeks of treatment.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG LEE011
Study Locations (1)
District of Columbia
- Lombardi Comprehensive Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2022-12 |
| Phase | Phase 1 |
What the registry record for NCT02985125 still lists
NCT02985125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT02985125 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02985125 about?
NCT02985125 is a clinical study titled "LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy". This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
What is the current status of trial NCT02985125?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2017-05-04. Estimated completion is 2022-12.
What conditions does trial NCT02985125 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT02985125?
The interventions under investigation include: Everolimus (DRUG), LEE011 (DRUG).
Who is sponsoring clinical trial NCT02985125?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02985125 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Pancreatic Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02985125's enrollment target sits among peer trials
44 20th of 37 higher than 18 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma 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.
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