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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00295243
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 25
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: Topotecan	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• 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
• Study Start Date: Sep 1, 2004
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. find the highest dose of GW572016 and Topotecan that can be safely given together []

2. Learn the side effects of GW572016 and Topotecan when given together []

3. Learn whether GW572016 changes how the body handles or processesTopotecan []

4. Learn whether Topotecan changes how the body handles or processes GW572016 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• GlaxoSmithKline

Investigators

• Principal Investigator: Charles Erlichman, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00295243
• Other Study ID Numbers: 1073-04; MC0315; 1073-04
• First Posted: Feb 23, 2006
• Last Update Posted: Jan 13, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Neoplasms; Topotecan

Study Results

No Results Posted as of Jan 13, 2011