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NCT00424840 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy

A Phase 1 study, sponsored by University of Massachusetts, Worcester.

Terminated
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00424840: Clinical Trial Phase 1 study, sponsored by University of Massachusetts, Worcester.

NCT00424840 is a Phase 1 study that was terminated before completion, run by University of Massachusetts, Worcester. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00424840, a Phase 1 study, was terminated before completion, sponsored by University of Massachusetts, Worcester.

TERMINATED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.

Primary Outcome

Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.

Interventions

  • DRUG Bevacizumab
  • DRUG Carboplatin AUC 6
  • DRUG Bortezomib 1.3 mg/m2
  • DRUG Bortezomib 1.6 mg/m2
  • DRUG Bortezomib 1.8 mg/m2

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2006-06
Est. Completion 2014-03
Phase Phase 1

Why NCT00424840 stopped before completion

NCT00424840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.

NCT00424840 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00424840 about?

NCT00424840 is a clinical study titled "Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy". A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this...

What is the current status of trial NCT00424840?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-06. Estimated completion is 2014-03.

What interventions are being tested in trial NCT00424840?

The interventions under investigation include: Bevacizumab (DRUG), Carboplatin AUC 6 (DRUG), Bortezomib 1.3 mg/m2 (DRUG), Bortezomib 1.6 mg/m2 (DRUG), Bortezomib 1.8 mg/m2 (DRUG).

Who is sponsoring clinical trial NCT00424840?

This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00424840's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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 NCT00424840, the US trial registry maintained by the National Library of Medicine. NCT00424840 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.