check_circleStudy Completed

Ovarian neoplasms

Bayer Identifier:

91476

ClinicalTrials.gov Identifier:

NCT00325351

EudraCT Number:

Not Available

EU CT Number:

Not Available
ZK-Epo given with carboplatin in patients with recurrent ovarian cancer

Trial purpose

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

Key Participants Requirements

Sex

Female

Age

18 Years
  • - Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit
  • - Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit

Trial summary

Enrollment Goal
45
Trial Dates
August 2006 - March 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Albuquerque, 87131, United States
Completed
Little Rock, 72205, United States
Completed
Toronto, M4N 3M5, Canada
Completed
Savannah, 31404, United States
Completed
Roanoke, 24014, United States
Completed
Bakersfield, 93309, United States
Completed
Cleveland, 44109, United States
Completed
Calgary, T2N 4N2, Canada
Completed
Winston-Salem, 27157, United States
Completed
Baltimore, 21204, United States
Completed
Oklahoma City, 73104, United States
Completed
Knoxville, 37920, United States
Completed
South Bend, 46617, United States
Completed
San Diego, 92121, United States
Completed
Tucson, 85724, United States
Completed
La Jolla, 92093, United States

Primary Outcome

  • Response to treatment with ZK-Epo after 6 cycles
    date_rangeTime Frame:
    After 6 cycles
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Safety and tolerability of ZK-Epo given with carboplatin
    date_rangeTime Frame:
    Sept. 2008
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Phase 1/2 study of ZK-Epothilone (ZK-Epo; ZK-219477) in combination with carboplatin in patients with platinum-sensitive recurrent ovarian cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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