CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Dose escalation followed by treatment with MTDdrug
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/NCT01647711
NCT01647711Phase 1Completed
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A Phase 1b Study of Intermittent Administration of High Doses of the Irreversible EGFR Inhibitor Afatinib as a Means of Achieving Plasma Levels Active Against Non-small Cell Lung Cancer With Known T790M Mutations

Boehringer Ingelheim·interventional·Posted Jul 23, 2012·Updated Jan 31, 2017

In Brief

A Phase 1 clinical trial evaluating Dose escalation followed by treatment with MTD for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A. The secondary objective is to explore tumor response and tumor-derived biological markers of response to afatinib, as well as pharmacokinetic parameters of afatinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2012
Enrollment StartJul 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.9 years ago

Interventions

Dose escalation followed by treatment with MTDdrug

Fixed 3+3 dose escalation; expansion of MTD cohort