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NCT00361088 · ClinicalTrials.gov registry record · Phase 1

A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma

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

Terminated
Registry status
Phase 1
Development phase
42
Enrollment target

NCT00361088 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 42 participants.

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The verdict

NCT00361088, 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
42 participants
Enrollment target

Study Summary

In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there is evidence of continued response for 8 cycles. Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months.

Interventions

  • DRUG PS-341
  • DRUG R11577

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2005-08
Est. Completion 2007-06
Phase Phase 1

What the Registry Record Tells You About NCT00361088

The ClinicalTrials.gov registry entry for NCT00361088 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 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 PS-341 is the first listed.

NCT00361088 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00361088 about?

NCT00361088 is a clinical study titled "A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma". In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there i...

What is the current status of trial NCT00361088?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2005-08. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00361088?

The interventions under investigation include: PS-341 (DRUG), R11577 (DRUG).

Who is sponsoring clinical trial NCT00361088?

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.