|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
TopoTarget A/S |
|---|---|
| Information provided by: | TopoTarget A/S |
| ClinicalTrials.gov Identifier: | NCT00413322 |
Purpose
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) |
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| 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 |