Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Boehringer Ingelheim
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.
Eligibility Criteria
Inclusion Criteria
Category 1, Gastric, GE junction, or Esophageal cancer Category 2, Biliary or gallbladder cancer Category 3, TCC urothelial tract, and Category 4, Gynecological cancers
Measurable disease by RECIST criteria.
Willingness and ability to give written informed consents consistent with ICHGCP guidelines.
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Treatment Details
Interventions
- BIBW 2992 (Afatinib) (Tyrosine Kinase Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BIBW 2992 (Afatinib)Experimental Treatment1 Intervention
BIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
1200.26.2 Boehringer Ingelheim Investigational SiteNew York, NY
1200.26.7 Boehringer Ingelheim Investigational SiteKettering, OH
1200.26.10 Boehringer Ingelheim Investigational SiteVancouver, WA
1200.26.13 Boehringer Ingelheim Investigational SiteLas Vegas, NV
More Trial Locations
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Who Is Running the Clinical Trial?
Boehringer IngelheimLead Sponsor