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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01251653
First received: December 1, 2010
Last updated: May 10, 2015
Last verified: May 2015
  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 : Adverse events : Patients with serious Adverse Events, [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Adverse Events: Patients with related Adverse Events defined as any AE related to Afatinib or Gemcitabine or Docetaxel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Adverse Events : Patients with AEs leading to drug discontinuation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Secondary objectives are: To investigate the PK characteristics of docetaxel or gemcitabine and of oral Afatinib in the tested treatment schedule : PK endpoints : The main PK parameters are to identify any drug - drug interaction. [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • Secondary objectives (efficay) are to assess the antitumor activity such as : Objective response and duration of the objective response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PK endpoints: Main PK parameters to identify any drug-drug interaction between Afatinib and Gemcitabine (AUC and Cmax). [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • PK endpoints : Main PK parameters to identify any drug-drug interaction between Afatinib and Docetaxel (AUC and Cmax). [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • Number of patient with the disease control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Pharmacokinetic samples


Enrollment: 94
Study Start Date: November 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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: May 10, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 29, 2015