GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

• ClinicalTrials.gov Identifier: NCT00044343
• Recruitment Status: Completed
• First Posted: August 28, 2002
• Last Update Posted: July 10, 2014
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: August 26, 2002
• First Posted Date: August 28, 2002
• Last Update Posted Date: July 10, 2014
• Study Start Date: September 2002
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 7, 2007): Tumor response rate (complete or partial). [ Time Frame: 6 Months ]
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00044343 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: September 7, 2007): Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers [ Time Frame: 6 Month ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
• Official Title: An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin
• Brief Summary: The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer
• Intervention: Drug: lapatinib
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 13, 2006): 80
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2003
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Provide signed informed consent.
• Refractory Stage IV metastatic colorectal cancer.
• Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
• No more than one prior therapy.
• Tumor tissue available for testing.
• 4 weeks since first-line cancer regimen.
• Able to swallow and retain oral medication.
• Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
• Adequate kidney and liver function.
• Adequate bone marrow function.

Exclusion Criteria:

• Pregnant or lactating female.
• Conditions that would affect absorption of an oral drug
• First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
• Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
• Severe cardiovascular disease or cardiac (heart) disease requiring a device.
• Active infection.
• Brain metastases.
• Concurrent cancer therapy or investigational therapy.
• Use of oral or intravenous steroids.
• Unresolved or unstable, serious toxicity from prior therapy.
• Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States, Canada

Administrative Information

• NCT Number: NCT00044343
• Other Study ID Numbers: EGF20004
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trial, MD; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: July 2014