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Sponsored by: |
TopoTarget A/S |
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Information provided by: | TopoTarget A/S |
ClinicalTrials.gov Identifier: | NCT00421889 |
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.
Condition | Intervention | Phase |
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Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer |
Drug: belinostat Drug: Paclitaxel Drug: Carboplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 32 |
Study Start Date: | September 2005 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ovarian patients:
Bladder patients:
All Patients:
Acceptable liver, renal and bone marrow function:
Exclusion Criteria:
Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures, including:
United States, California | |
Gynecologic Oncology Associates | |
Newport Beach, California, United States, 92663 | |
United States, Florida | |
Research Facility | |
Orlando, Florida, United States, 32804 | |
United States, Louisiana | |
Hematology & Oncology Specialists, LLC | |
Metairie, Louisiana, United States, 70006 | |
Hematology and Oncology Specialists, LLC | |
Covington, Louisiana, United States, 70433 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Rhode Island | |
Women & Infants Hospital of Rhode Island | |
Providence, Rhode Island, United States, 02905 | |
Denmark | |
Research Facility | |
Copenhagen, Denmark, 2100 | |
Research Facility | |
Herlev, Denmark, 2730 | |
United Kingdom | |
Research Facility | |
Surrey, United Kingdom, SW3 6JJ | |
Research Facility | |
Glasgow, United Kingdom, G120YN |
Responsible Party: | TopoTarget A/S ( Jan Fagerberg/Medical Director ) |
Study ID Numbers: | PXD101-CLN-8, PXD101-040-EU |
Study First Received: | January 12, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00421889 History of Changes |
Health Authority: | United States: Food and Drug Administration; Denmark: Danish Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Ovarian cancer Ovarian Neoplasms Primary peritoneal Epithelial ovarian |
Fallopian tube belinostat PXD101 mixed mullerian cancer of ovarian origin |
Fallopian Tube Cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases |
Ovarian Epithelial Cancer Fallopian Tube Neoplasms Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases Pharmacologic Actions |
Fallopian Tube Neoplasms Adnexal Diseases Fallopian Tube Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |