CT-2106 for the Second Line Treatment of Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00291837
First received: February 14, 2006
Last updated: February 24, 2010
Last verified: February 2010

February 14, 2006
February 24, 2010
November 2004
June 2006   (final data collection date for primary outcome measure)
response rate
Same as current
Complete list of historical versions of study NCT00291837 on ClinicalTrials.gov Archive Site
  • toxicity
  • response duration
  • time to progression
  • survival
Same as current
Not Provided
Not Provided
 
CT-2106 for the Second Line Treatment of Ovarian Cancer
Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: CT-2106
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
  • Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
  • At least one measurable lesion according to RECIST
  • ECOG performance status 0 or 1
  • at least 18 years old
  • Adequate haematological function
  • Adequate renal and hepatic functions
  • Normal coagulation parameters

Exclusion Criteria:

  • Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months
  • Pregnant or lactating patients
  • Prior treatment with camptothecins
  • Presence or history of CNS metastasis or carcinomatous leptomeningitis;
  • Current active infection per investigator assessment;
  • Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
  • Current history of chronic diarrhea >= grade 1 (CTCAE version 3);
  • Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
  • Other uncontrolled, serious illness or medical condition, as determined by the investigator;
  • Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
  • Concurrent treatment with any other anti-cancer therapy;
  • Known HIV positivity or AIDS-related illness;
  • Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United Kingdom
 
NCT00291837
CAM203
Not Provided
Not Provided
CTI BioPharma
Not Provided
Principal Investigator: Hilary Calvert, PhD Newcastle General Hospital
CTI BioPharma
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP