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

NCT ID: NCT01251653

Last Updated: 2016-05-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Afatinib and docetaxel

Afatinib

Intervention Type DRUG

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

docetaxel

Intervention Type DRUG

Maximum Tolerated Dose of Afatinib in combination with docetaxel

Afatinib and gemcitabine

Afatinib

Intervention Type DRUG

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

gemcitabine

Intervention Type DRUG

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Interventions

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Afatinib

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Intervention Type DRUG

Afatinib

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Intervention Type DRUG

docetaxel

Maximum Tolerated Dose of Afatinib in combination with docetaxel

Intervention Type DRUG

gemcitabine

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.93.33002 Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1200.93.33001 Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1200.93.33003 Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

Countries

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France

References

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Hiret S, Isambert N, Gomez-Roca C, Bennouna J, Sassi M, de Mont-Serrat H, Fan J, Schnell D, Delord JP. Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors. Invest New Drugs. 2018 Dec;36(6):1044-1059. doi: 10.1007/s10637-018-0601-1. Epub 2018 May 29.

Reference Type DERIVED
PMID: 29808308 (View on PubMed)

Other Identifiers

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2010-020560-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.93

Identifier Type: -

Identifier Source: org_study_id