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Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i.v. and vinorelbine oral.

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

France: AFFSAPS

Study ID:

1200.69

NCT ID:

NCT00906698

Start Date:

May 2009

Completion Date:

January 2013

Related Keywords:

  • Neoplasms
  • Neoplasms

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