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Sponsors and Collaborators: |
Duke University Bristol-Myers Squibb |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00598091 |
The purpose of this study is to find the highest dose of the drugs gemcitabine and dasatinib that can be given for the treatment of pancreatic cancer.
Gemcitabine (also called Gemzar™)is a drug that is given intravenously. Dasatinib (also called Sprycel™) is a tablet and will be taken by mouth.
Gemcitabine is approved by the Food and Drug Administration (FDA) for the treatment of advanced breast, lung and pancreatic cancer. Dasatinib is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients that are resistant to imatinib mesylate (Gleevec™ ).
This study will try to find the highest doses of these drugs that can be tolerated when taken in combination. The study will also look at how the drugs work in the body, and will see if there is any effect on pancreatic cancer.
Condition | Intervention | Phase |
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Refractory Solid Tumors Pancreatic Adenocarcinoma |
Drug: gemcitabine Drug: dasatinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of the Combination of Gemcitabine Plus Dasatinib in Patients With Refractory Solid Tumors With an Expanded Cohort in Advanced Pancreatic Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: gemcitabine
1000mg/m2, Days 1, 8, 15
Drug: dasatinib
50mg, PO, QD
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B: Active Comparator |
Drug: gemcitabine
1000mg/m2, days 1, 8, 15
Drug: dasatinib
50mg, PO, BID
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This open-label, multicenter, non-randomized phase I trial of gemcitabine plus once and twice daily dasatinib is designed to assess the safety, tolerability, maximum tolerated dose/recommended phase II dose, and preliminary efficacy of this combination in adult patients with advanced solid tumors and with previously untreated metastatic pancreatic cancer. Patients will be accrued at Duke University Medical Center, the Duke Oncology Network, the University of North Carolina at Chapel Hill and Wake Forest Baptist Medical Center
Patients will be accrued to either of the gemcitabine/dasatinib arms in alternating sequential order. In the case where there is an open slot on a particular arm but not the alternative, the enrolled patient will be assigned to that open slot. For example, at the start of the trial, patient #1 will be treated on the gemcitabine with dasatinib twice daily dosing arm, patient #2 on the gemcitabine with dasatinib once daily dosing arm, patient #3 on the gemcitabine with dasatinib twice daily dosing arm, and so on. However, if, due to cohort expansion there is a slot available on one treatment arm but not the other, the patient will be accrued to the open slot.
Additionally, if one arm is held, delayed, or not pursued, accrual to the alternate arm may continue. Patients and their treating physicians will not be able to choose on their own which treatment arm that patient will be assigned to. This enrollment procedure will be the procedure for the entire trial.
For the dose escalation portion of the trial, patients will only be accrued at Duke University Medical Center. For the expanded cohort portion of patients with previously untreated metastatic pancreatic cancer treated at the recommended phase II dose of each arm, patients may be accrued at Duke University Medical Center,and the sites listed above.
NOTE: The first stage closed as of December 2008. Subjects will only be enrolled into the second stage of the this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligibility Criteria Specific for Dose Escalation Phase
Eligibly Criteria Specific for Expansion Phase at Recommended Phase II Dose
Eligibility Criteria for All Subjects
Exclusion Criteria:
Contact: Amy Franklin, BA | 919-668-1861 | Amy.Franklin@duke.edu |
Contact: Anthony Amara, MSW | 919-668-1861 | Anthony.Amara@duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Anthony Amara, MSW 919-668-3046 Anthony.Amara@duke.edu | |
Contact: Wanda Honeycutt, RN 919 -668-1861 Wanda.Honeycutt@duke.edu | |
UNC Lineberger, Comprehensive Cancer Center | Not yet recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Sub-Investigator: Richard Goldberg, MD | |
Wake Forest Baptist Medical Center | Not yet recruiting |
Winston-Salem, North Carolina, United States | |
Sub-Investigator: Mebea Aklilu, MD |
Principal Investigator: | Hope C Uronis, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Hope Uronis, MD ) |
Study ID Numbers: | 9335 |
Study First Received: | December 26, 2007 |
Last Updated: | March 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00598091 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Solid Tumors Phase I Expanded Cohort |
Pancreatic Cancer Dasatinib Gemcitabine |
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Carcinoma Digestive System Diseases |
Radiation-Sensitizing Agents Dasatinib Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Protein Kinase Inhibitors Neoplasms by Site Dasatinib Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms |
Digestive System Neoplasms Neoplasms by Histologic Type Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |