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Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

NCT00851045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

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 irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Conditions

  • Colorectal Cancer (CRC)

Interventions

DRUG

Irinotecan

Solution, IV, 180 mg/m2, Q14 days, Until PD

DRUG

5-Fluorouracil (bolus)

Solution, IV, 400 mg/m2, Q14 days, Until PD

DRUG

5-Fluorouracil (infusional)

Solution, IV, 2400 mg/m2, Q14 days, Until PD

DRUG

Leucovorin calcium

Solution, IV, 400 mg/m2, Q14 days, Until PD

DRUG

CT-322

Solution, IV, 2 mg/kg, Q7 days, Until PD

DRUG

Bevacizumab

Solutions, IV, 5 mg/kg, Q14 days, Until PD

DRUG

Bevacizumab Placebo (saline solution)

Solution, IV, 0 mg/kg, On day 8 of a 2-week 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
2009-10-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States
  • Argentina
  • Italy

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 NCT00851045 on ClinicalTrials.gov