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NCT02729194 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma
A Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT02729194: Completed Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT02729194 is a Early Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02729194, a Early Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators hypothesize that administration of pazopanib with low fat meal would be safe and feasible with secondary implications of higher pazopanib levels; potentially translating into greater anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the proposed pilot study, investigators seek to test the feasibility and practicality of this approach and gather preliminary data on adverse effects and the safety profile. Investigators hope to ameliorate any potential for greater toxicities with a dynamic dosing design that incorporates adverse events from each cycle into dosing for the next cycle and a structured symptom specific plan.
Primary Outcome
Number of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.
Interventions
- DRUG Pazopanib
- OTHER Low Fat Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-09 |
| Phase | Early Phase 1 |
What the finished NCT02729194 record still lists
NCT02729194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Pazopanib is the first listed.
NCT02729194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02729194 about?
NCT02729194 is a clinical study titled "Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma". Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved for advanced renal cell carc...
What is the current status of trial NCT02729194?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2016-06. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02729194?
The interventions under investigation include: Pazopanib (DRUG), Low Fat Diet (OTHER).
Who is sponsoring clinical trial NCT02729194?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02729194's enrollment target sits among peer trials
16 1369th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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