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NCT00536575 · ClinicalTrials.gov registry record · Phase 1

Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients

A Phase 1 study, sponsored by SCRI Development Innovations.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT00536575: Completed Phase 1 study, sponsored by SCRI Development Innovations.

NCT00536575 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00536575, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. The initial patients on the dose-finding portion of this study will be enrolled through a single institution. Following establishment of the Phase II dose the study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium. The purpose of this study is to develop the combination of bortezomib (which is proven to be clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of angiogenesis). This regimen will be developed in a schedule that is convenient for patients, and that is as minimally toxic to patients as possible.

Primary Outcome

The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.

Interventions

  • DRUG Bortezomib
  • DRUG Sorafenib

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2007-11
Est. Completion 2010-08
Phase Phase 1
SCRI Development Innovations

146 total trials

What the finished NCT00536575 record still lists

NCT00536575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

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

NCT00536575 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00536575 about?

NCT00536575 is a clinical study titled "Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients". This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. The initial patients on the dose-finding portion of this study will be enrolled through a single institution. Following establishment of the Phase II dose the study will open enrollment thro...

What is the current status of trial NCT00536575?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2007-11. Estimated completion is 2010-08.

What interventions are being tested in trial NCT00536575?

The interventions under investigation include: Bortezomib (DRUG), Sorafenib (DRUG).

Who is sponsoring clinical trial NCT00536575?

This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00536575's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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Source: ClinicalTrials.gov NCT00536575, the US trial registry maintained by the National Library of Medicine. NCT00536575 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.