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A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

NCT00831636 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-09-13

No results posted yet for this study

Summary

This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design

Conditions

Interventions

DRUG

CP-4055

D1-5 and D8(+2)-12(+2) q4w

DRUG

CP-4055

IV administration day 1-5 and day 8-12 in a 4 week schedule

Sponsors & Collaborators

  • Clavis Pharma

    lead INDUSTRY

Principal Investigators

  • Sandro Pignata, MD · Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • Belgium
  • Italy

Study Locations

More Related Trials

Entities

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 NCT00831636 on ClinicalTrials.gov