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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

Hilary Calvert, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Newcastle General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

CAM203

NCT ID:

NCT00291837

Start Date:

November 2004

Completion Date:

December 2007

Related Keywords:

  • Ovarian Cancer
  • ovarian
  • CT-2106
  • Ovarian Neoplasms

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