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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251653
• Other study ID #: 1200.93
• Secondary ID: 2010-020560-37
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: May 10, 2015
• Start date: November 2010
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Afatinib
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
• Afatinib
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
• docetaxel
Maximum Tolerated Dose of Afatinib in combination with docetaxel
• gemcitabine
Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 weeks	No
Secondary	Secondary objectives are : To assess the safety of the combination : Adverse events : Patients with serious Adverse Events,		6 months	Yes
Secondary	Adverse Events: Patients with related Adverse Events defined as any AE related to Afatinib or Gemcitabine or Docetaxel		6 months	Yes
Secondary	Adverse Events : Patients with AEs leading to drug discontinuation		6 months	Yes
Secondary	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.		24 days	Yes
Secondary	Secondary objectives (efficay) are to assess the antitumor activity such as : Objective response and duration of the objective response		6 months	No
Secondary	PK endpoints: Main PK parameters to identify any drug-drug interaction between Afatinib and Gemcitabine (AUC and Cmax).		24 days	Yes
Secondary	PK endpoints : Main PK parameters to identify any drug-drug interaction between Afatinib and Docetaxel (AUC and Cmax).		24 days	Yes
Secondary	Number of patient with the disease control		6 months	No