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Sponsored by: |
TopoTarget A/S |
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Information provided by: | TopoTarget A/S |
ClinicalTrials.gov Identifier: | NCT00413322 |
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
Condition | Intervention | Phase |
---|---|---|
Tumor |
Drug: belinostat Drug: 5-Fluorouracil (5-FU) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors |
Enrollment: | 35 |
Study Start Date: | September 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acceptable liver function:
Acceptable renal function:
Acceptable hematologic status:
Acceptable coagulation status:
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic Arizona | |
Scottsdale, Arizona, United States, 85259 | |
United States, Nebraska | |
University of Nebraska | |
Omaha, Nebraska, United States, 68198-7680 | |
United States, New Hampshire | |
Portsmouth Regional Hospital Hematology/Oncology Clinic | |
Portsmouth, New Hampshire, United States, 03801 |
Responsible Party: | TopoTarget A/S ( Jan Fagerberg/Medical Director ) |
Study ID Numbers: | PXD101-CLN-4 |
Study First Received: | December 18, 2006 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00413322 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Solid tumor Adenosarcoma Androgen-independent prostate cancer belinostat bladder cancer bladder neoplasms Breast cancer Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Carcinosarcoma Chondrosarcoma Coin Lesion, Pulmonary Coin Lesion, Pulmonary colorectal cancer |
Esophageal Neoplasms Facial Neoplasms Fibrosarcoma head and neck cancer Hemangiosarcoma Histiocytoma, Malignant Fibrous kidney cancer Leiomyosarcoma Liposarcoma lung cancer lung neoplasms Lymphangiosarcoma mesothelioma mesothelioma, cystic Mixed Tumor, Mesodermal |
Fibrosarcoma Otorhinolaryngologic Neoplasms Mouth Neoplasms Lung Neoplasms Hemangioma Ovarian Cancer Osteogenic Sarcoma Urinary Bladder Neoplasms Breast Neoplasms Esophageal Cancer Carcinoma Oral Cancer Carcinoma, Small Cell Liposarcoma Malignant Mesenchymal Tumor |
Histiocytoma Esophageal Disorder Fluorouracil Sarcoma Esophageal Diseases Adenoma, Pleomorphic Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Antimetabolites Histiocytoma, Malignant Fibrous Immunologic Factors Leiomyosarcoma Esophageal Neoplasms Cystosarcoma Phyllodes Dermatofibroma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Fluorouracil Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |