BIBW 2992 and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms
Intervention: BIBW 2992 20 mg/day (Drug); BIBW 2992 20 mg/day (Drug); BIBW 2992 40 mg/day (Drug); BIBW 2992 40 mg/day (Drug); BIBW 2992 50 mg/day (Drug); BIBW 2992 50 mg/day (Drug); Vinorelbine per os 60 mg/m² (Drug); Vinorelbine per os 80 mg/m² (Drug); Vinorelbine i.v 25 mg/m² (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i. v. and oral
Safety and anti-tumour efficacy data and determination of pharmacokinetic characteristics of
BIBW 2992, vinorelbine i. v. and vinorelbine oral.
Clinical Details
Official title: Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i.v. and vinorelbine oral.
Secondary outcome: Incidence and intensity of AE according to CTC v.3Pharmacokinetic characteristics of BIBW 2992, vinorelbine i.v. and vinorelbine oral Overall response according to the RECIST criteria To determine the pharmacodynamic parameters (microarray and proteomic analyses) associated with response to BIBW 2992-vinorelbine
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of malignancy that is now
advanced, non resectable and/or metastatic
- Tumours historically known to overexpress EGFR and/or HER2
Exclusion Criteria:
- Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start
of therapy or concomitantly with this trial.
- Prior treatment with EGFR inhibiting drugs within the past two weeks before the start
of therapy or concomitantly with this trial.
- Prior treatment with HER2 inhibiting drugs within the past two weeks before the start
of therapy or concomitantly with this trial.
Locations and Contacts
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
1200.69.3301A Boehringer Ingelheim Investigational Site, Toulouse Cedex, France; Recruiting
1200.69.3302A Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
1200.69.3302B Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
1200.69.3302F Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
1200.69.3302D Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
1200.69.3302E Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
1200.69.3302C Boehringer Ingelheim Investigational Site, Villejuif Cedex, France; Recruiting
Additional Information
Starting date: May 2009
Last updated: September 14, 2010
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