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NCT01100242 · ClinicalTrials.gov registry record · Phase 2

Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

A Phase 2 study, sponsored by New Mexico Cancer Research Alliance.

Terminated
Registry status
Phase 2
Development phase
17
Enrollment target

NCT01100242: Clinical Trial Phase 2 study, sponsored by New Mexico Cancer Research Alliance.

NCT01100242 is a Phase 2 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01100242, a Phase 2 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.

TERMINATED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

This is an open label, non-randomized, single arm phase II study. The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary objectives of this study are to: Assess the response rate of this combination in this patient population and Assess the toxicity of this combination in this patient population

Primary Outcome

Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the

Interventions

  • DRUG Velcade and Sorafenib

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2010-04
Est. Completion 2015-02
Phase Phase 2

Why NCT01100242 stopped before completion

NCT01100242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which Velcade and Sorafenib is the first listed.

NCT01100242 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01100242 about?

NCT01100242 is a clinical study titled "Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma". This is an open label, non-randomized, single arm phase II study. The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary objectives of this study are to:...

What is the current status of trial NCT01100242?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-04. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01100242?

The interventions under investigation include: Velcade and Sorafenib (DRUG).

Who is sponsoring clinical trial NCT01100242?

This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01100242's enrollment target sits among peer trials

17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01100242, the US trial registry maintained by the National Library of Medicine. NCT01100242 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.