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CY-503 for the Treatment of Chemotherapy-refractory Metastatic Colorectal Cancer

NCT00932724 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2013-07-10

No results posted yet for this study

Summary

This trial is designed as a phase II evaluation of the effect of CY-503 or placebo on progression free survival (PFS) defined as the time from start of treatment until the objective observation of progressive disease (PD) or death from any course in patients with chemotherapy-refractory metastatic colorectal cancer.

Conditions

Interventions

DRUG

CY-503

Ampoules with 1 ml 350 ng CY-503 solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks

DRUG

Placebo

Ampoules with 1 ml placebo solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Medical University Innsbruck

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Cytavis Biopharma GmbH

    lead INDUSTRY

Principal Investigators

  • Heinz Zwierzina, MD · University Hospital Innsbruck, Austria

  • Lothar Bergmann, MD · University Hospital, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00932724 on ClinicalTrials.gov