CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Afatinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01251653
NCT01251653N/ACompleted
CompareCT.gov

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.

Boehringer Ingelheim·observational·Posted Dec 2, 2010·Updated May 30, 2016

In Brief

An observational study evaluating Afatinib, docetaxel, and 1 other intervention for Neoplasms. Completed, enrolled 94 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.6 years ago

Interventions

Afatinibdrug

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Afatinibdrug

Maximum Tolerated Dose of Afatinib in combination with gemcitabine

docetaxeldrug

Maximum Tolerated Dose of Afatinib in combination with docetaxel

gemcitabinedrug

Maximum Tolerated Dose of Afatinib in combination with gemcitabine