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Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00906698
First received: May 14, 2009
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Neoplasms
 Drug: BIBW 2992 low dosage
Drug: BIBW 2992 high dosage
Drug: BIBW 2992 50 mg/day
Drug: BIBW 2992 20 mg/day
Drug: BIBW 2992 40 mg/day
Drug: BIBW 2992 medium dosage
Drug: Vinorelbine per os 60 mg/m²
Drug: Vinorelbine per os 80 mg/m²
Drug: Vinorelbine i.v or per os
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i.v. and vinorelbine oral. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and intensity of AE according to NCI CTCAE classification v.3 [ Time Frame: This endpoint has no specific timeframe ] [ Designated as safety issue: No ]
  • Pharmacokinetic characteristics of BIBW 2992, vinorelbine i.v. and vinorelbine oral [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Overall response according to the RECIST criteria [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: May 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBW 2992 and vinorelbine i.v
Low, medium and high dosages of BIBW 2992 with standard dosage of vinorelbine i.v.
 Drug: BIBW 2992 low dosage
Patients will receive low dosage of BIBW 2992 plus standard dosage of vinorelbine
Drug: BIBW 2992 high dosage
Patients will receive high dosage of BIBW 2992 plus standard dosage of vinorelbine
Drug: BIBW 2992 medium dosage
Patients will receive medium dosage of BIBW 2992 plus standard dosage of vinorelbine
Drug: Vinorelbine i.v or per os
Patients will receive 25 mg/m² of Vinorelbine i.v or per os
Experimental: BIBW 2992 and vinorelbine per os
Low, medium and high dosages of BIBW 2992 with standard dosage of vinorelbine per os
 Drug: BIBW 2992 50 mg/day
Patients will receive 50 mg/day of BIBW 2992 plus standard dosage of vinorelbine
Drug: BIBW 2992 20 mg/day
Patients will receive 20 mg/day of BIBW 2992 plus standard dosage of vinorelbine
Drug: BIBW 2992 40 mg/day
Patients will receive 40 mg/day of BIBW 2992 plus standard dosage of vinorelbine
Drug: Vinorelbine per os 60 mg/m²
Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15
Drug: Vinorelbine per os 80 mg/m²
Patients will receive 80 mg/m² Vinorelbine per os at J22

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906698

Locations
France
1200.69.3301H Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
1200.69.3301G Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
1200.69.3301F Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
1200.69.3301A Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
1200.69.3301C Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
1200.69.3302E Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302D Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302C Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302B Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302G Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302A Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
1200.69.3302H Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00906698     History of Changes
Other Study ID Numbers: 1200.69, 2008-006290-32
Study First Received: May 14, 2009
Last Updated: March 6, 2013
Health Authority: France: AFFSAPS

Additional relevant MeSH terms:
Neoplasms
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013