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: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Neoplasms
Drug: Afatinib
Drug: docetaxel
Drug: gemcitabine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Pharmacokinetic samples


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Afatinib and docetaxel Drug: Afatinib
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
Drug: docetaxel
Maximum Tolerated Dose of Afatinib in combination with docetaxel
Afatinib and gemcitabine Drug: Afatinib
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
Drug: gemcitabine
Maximum Tolerated Dose of Afatinib in combination with gemcitabine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

solid tumors

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251653

Locations
France
1200.93.33002 Boehringer Ingelheim Investigational Site
Dijon, France
1200.93.33001 Boehringer Ingelheim Investigational Site
Saint-Herblain cedex, France
1200.93.33003 Boehringer Ingelheim Investigational Site
Toulouse Cedex, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01251653     History of Changes
Other Study ID Numbers: 1200.93, 2010-020560-37
Study First Received: December 1, 2010
Last Updated: April 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014