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Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

NCT00850577 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2015-10-12

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Paclitaxel

Solution, IV, 200 mg/m2, Q21days, 6 cycles

DRUG

Carboplatin

Solution, IV, AUC=6, Q21days, 6 cycles

DRUG

CT-322

Solution, IV, 2 mg/kg, Q7days, Until PD

DRUG

Bevacizumab

Solution, IV, 15 mg/kg, Q21days, Until PD

DRUG

Bevacizumab placebo (ie saline solution)

Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • Brazil
  • France
  • Italy
  • Poland
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850577 on ClinicalTrials.gov