Spots Global Cancer Trial Database for A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment
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Trial Identification
Brief Title: A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment
Official Title: A Phase I/II Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients With Advanced Solid Tumours
Study ID: NCT00421889
Study Description
Brief Summary: The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in ovarian and bladder cancer patients The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder cancer patients. Enrollment of ovarian patients is complete.
Detailed Description: MTD Expansion I(Phase II): A total of 18-32 patients with epithelial ovarian, primary peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin, in need of relapse treatment will be enrolled. MTD Expansion II (phase II): A total of 15 patients with urothelial (transitional cell) carcinoma of the bladder will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Gynecologic Oncology Associates, Newport Beach, California, United States
Research Facility, Orlando, Florida, United States
Hematology and Oncology Specialists, LLC, Covington, Louisiana, United States
Hematology & Oncology Specialists, LLC, Metairie, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States
The Finsen Center, Rigshospitalet, Copenhagen, , Denmark
Research Facility, Herlev University Hospital, Herlev, , Denmark
The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
The Royal Marsden NHS Trust, Surrey, , United Kingdom
Contact Details
Name: e-mail contact via enquires@topotarget.com
Affiliation: Valerio Therapeutics
Role: STUDY_DIRECTOR
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