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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00295243
First received: February 21, 2006
Last updated: January 12, 2011
Last verified: January 2011
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 1073-04
Study First Received: February 21, 2006
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014