A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01251653
First received: December 1, 2010
Last updated: September 3, 2014
Last verified: September 2014

December 1, 2010
September 3, 2014
November 2010
November 2014   (final data collection date for primary 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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01251653 on ClinicalTrials.gov Archive Site
  • Secondary objectives are : To assess the safety of the combination [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Secondary objectives are: To investigate the PK characteristics of docetaxel or gemcitabine and of oral Afatinib in the tested treatment schedule [ Time Frame: 23 days ] [ Designated as safety issue: No ]
  • Secondary objectives are: To assess antitumor activity [ Time Frame: Until progression ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel
A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.

To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.

To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Pharmacokinetic samples

Non-Probability Sample

solid tumors

Neoplasms
  • Drug: Afatinib
    Maximum Tolerated Dose of Afatinib in combination with gemcitabine
  • Drug: docetaxel
    Maximum Tolerated Dose of Afatinib in combination with docetaxel
  • Drug: gemcitabine
    Maximum Tolerated Dose of Afatinib in combination with gemcitabine
  • Afatinib and docetaxel
    Interventions:
    • Drug: Afatinib
    • Drug: docetaxel
  • Afatinib and gemcitabine
    Interventions:
    • Drug: Afatinib
    • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01251653
1200.93, 2010-020560-37
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP