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

NCT01251653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2016-05-30

Study results available
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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.

Conditions

  • Neoplasms

Interventions

DRUG

Afatinib

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251653 on ClinicalTrials.gov