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Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295243
First Posted: February 23, 2006
Last Update Posted: January 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Mayo Clinic
  Purpose
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15.

Condition Intervention Phase
Advanced Solid Malignancies Drug: Topotecan Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • find the highest dose of GW572016 and Topotecan that can be safely given together
  • Learn the side effects of GW572016 and Topotecan when given together
  • Learn whether GW572016 changes how the body handles or processesTopotecan
  • Learn whether Topotecan changes how the body handles or processes GW572016

Estimated Enrollment: 25
Study Start Date: September 2004
Study Completion Date: November 2006
Detailed Description:
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will be required to spend the evening before Day 1 in the General Clinical Research Center and frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life expectancy of more than 12 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295243


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
GlaxoSmithKline
Investigators
Principal Investigator: Charles Erlichman, M.D. Mayo Clinic
  More Information

Responsible Party: Julian R. Molina, M.D., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00295243     History of Changes
Other Study ID Numbers: 1073-04
MC0315 ( Other Identifier: Mayo Clinic Cancer Center )
1073-04 ( Other Identifier: Mayo Clinic IRB )
First Submitted: February 21, 2006
First Posted: February 23, 2006
Last Update Posted: January 13, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Neoplasms
Topotecan
Lapatinib
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors