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NCT00496223 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Study of Sunitinib and Dacarbazine

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
Phase 1
Development phase
11
Enrollment target

NCT00496223 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 11 participants.

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The verdict

NCT00496223, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study Summary

This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. If a clinical response is seen, patients will continue to be enrolled.

Interventions

  • DRUG Sunitinib
  • DRUG Dacarbazine

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2006-09
Est. Completion 2007-06
Phase Phase 1

What the Registry Record Tells You About NCT00496223

The ClinicalTrials.gov registry entry for NCT00496223 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.

NCT00496223 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00496223 about?

NCT00496223 is a clinical study titled "A Phase I/II Study of Sunitinib and Dacarbazine". This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will b...

What is the current status of trial NCT00496223?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2006-09. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00496223?

The interventions under investigation include: Sunitinib (DRUG), Dacarbazine (DRUG).

Who is sponsoring clinical trial NCT00496223?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.