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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 is a Early Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02729194
The ClinicalTrials.gov registry entry for NCT02729194 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pazopanib is the first listed.
NCT02729194 reports 0 study locations.
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.
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