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Sponsors and Collaborators: |
Threshold Pharmaceuticals PPD |
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Information provided by: | Threshold Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00102752 |
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
Condition | Intervention | Phase |
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Neoplasms Pancreatic Neoplasms |
Drug: Glufosfamide Drug: Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma |
Estimated Enrollment: | 47 |
Study Start Date: | December 2004 |
This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.
Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
United States, Arizona | |
Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, Indiana | |
Indiana Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kentucky | |
Norton Healthcare Cancer Center | |
Louisville, Kentucky, United States, 40202 | |
Brazil, BH | |
Hospital de Doenças Cardiovasculares - Biocor | |
Nova Lima, BH, Brazil, 34000-000 | |
Brazil, RS | |
Hospital Nossa Senhora da Conceição | |
Porto Alegre, RS, Brazil, 91350-200 | |
Hospital Mãe de Deus | |
Porto Alegre, RS, Brazil, 90880-480 | |
Brazil, SP | |
Fundação Pio XII - Hospital de Câncer de Barretos | |
Barretos, SP, Brazil, 14784-400 | |
Universidade Federal de São Paulo - Hospital São Paulo | |
São Paulo, SP, Brazil, 04023-900 | |
Hospital Israelita Albert Einstein | |
São Paulo, SP, Brazil, 05651-901 |
Study ID Numbers: | TH-CR-301 |
Study First Received: | February 1, 2005 |
Last Updated: | August 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00102752 |
Health Authority: | United States: Food and Drug Administration |
Pancreas Cancer Metastatic Glufosfamide Advanced |
Solid Tumor Advanced Solid Tumors Pancreatic Adenocarcinoma |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |