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A Phase I Dose Escalation Trial of Once Daily Oral Treatment BIBW 2992 Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.


N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

A Phase I Dose Escalation Trial of Once Daily Oral Treatment BIBW 2992 Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.

Inclusion Criteria


Inclusion criteria:

1. histologically or cytologically confirmed diagnosis of any advanced or metastatic
relapsed or refractory solid tumor.

Exclusion criteria:

1. Active brain metastases

2. Patients with known pre-existing interstitial lung disease

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The primary objective is to determine the maximum tolerated dose (MTD) of oral Afatinib given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

1200.93

NCT ID:

NCT01251653

Start Date:

November 2010

Completion Date:

April 2014

Related Keywords:

  • Neoplasms
  • Neoplasms

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