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NCT03109015 · ClinicalTrials.gov registry record · Phase 2

Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing

A Phase 2 study of Carcinoma, Renal Cell, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
7
Enrollment target
1
Study location

NCT03109015 is a Phase 2 study of Carcinoma, Renal Cell that has completed, run by Duke University. The registered enrollment target is 7 participants, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03109015, a Phase 2 study of Carcinoma, Renal Cell, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the effect of a sunitinib administration schedule 2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal cell carcinoma. Subjects will be randomized 1:1 to one of two arms: 4/2 schedule of sunitinib administration or 2/1 schedule of sunitinib administration. Cardiopulmonary function will be assessed at baseline, week 4 (4/2 schedule only), week 5 (2/1 schedule only) and week 12. The investigators hypothesize that schedule 2/1 of sunitinib is not only better tolerated but will be associated with less fatigue and functional cardiovascular/muscular toxicity than the 4/2 schedule.

Conditions Studied

Interventions

  • DRUG Sunitinib

Study Locations (1)

North Carolina

  • Duke Cancer Institute - Durham

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2017-09-27
Est. Completion 2019-10-08
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT03109015

The ClinicalTrials.gov registry entry for NCT03109015 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (98% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 1 intervention - of which Sunitinib is the first listed.

NCT03109015 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT03109015 about?

NCT03109015 is a clinical study titled "Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing". The purpose of this study is to determine the effect of a sunitinib administration schedule 2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal cell carcinoma. Subjects ...

What is the current status of trial NCT03109015?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2017-09-27. Estimated completion is 2019-10-08.

What conditions does trial NCT03109015 study?

This clinical trial studies the following conditions: Carcinoma, Renal Cell.

What interventions are being tested in trial NCT03109015?

The interventions under investigation include: Sunitinib (DRUG).

Who is sponsoring clinical trial NCT03109015?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03109015 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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