CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Brigatinibdrug
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/NCT01449461
NCT01449461Phase 2Completed
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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113

Ariad Pharmaceuticals·interventional·Posted Oct 10, 2011·Updated Aug 17, 2021

In Brief

A Phase 2 clinical trial evaluating Brigatinib for Lymphoma, Large-Cell, Anaplastic and Carcinoma, Non-Small-Cell Lung. Completed, enrolled 137 participants.

Detailed Summary

The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to determine the safety profile of orally administered brigatinib, including: the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer (NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Large-Cell, Anaplastic, Carcinoma, Non-Small-Cell Lung
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2011
Enrollment StartSep 20, 2011
Primary CompletionNov 16, 2015
Study CompletionFeb 18, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.7 years ago

Interventions

Brigatinibdrug

Brigatinib tablets and capsules.