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Sponsors and Collaborators: |
Brown University GlaxoSmithKline |
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Information provided by: | Brown University |
ClinicalTrials.gov Identifier: | NCT00439179 |
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
Condition | Intervention | Phase |
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Metastatic Pancreatic Cancer |
Drug: Gemcitabine Drug: Lapatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556 |
Estimated Enrollment: | 37 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.
Trial finished and no further data will be collected.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following:
Double barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm)
Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GW572016, breastfeeding should be discontinued if the mother is treated with GW572016.
United States, Rhode Island | |
brown University oncology group | |
providence, Rhode Island, United States, 02912 |
Principal Investigator: | howard Safran, MD | Brown University |
Study ID Numbers: | BrUOG-PA-205 |
Study First Received: | February 22, 2007 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00439179 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Cancer |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Lapatinib Immunosuppressive Agents Antiviral Agents |
Oxaliplatin Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |