NCT01449461

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Ariad Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people with NSCLC. This study will look at the safety, tolerability and efficacy of brigatinib. The study enrolled 137 patients. Participants were assigned to one of the following treatment groups: * Brigatinib 30 mg once daily (QD)/60 mg QD * Brigatinib 90 mg QD * Brigatinib 120 mg QD/60 mg twice daily (BID) * Brigatinib 90 mg QD-180 mg QD * Brigatinib 180 mg QD/90 mg BID * Brigatinib 240 mg QD/120 mg BID/300 mg QD This multi-center trial will be conducted worldwide. The overall expected time to participate in this study is approximately 4 years. Participants will make multiple visits to the clinic, and 30 days after the End-of-Treatment visit. Follow-up is intended to continue for at least 2 years after the initial dose.

Conditions

• Lymphoma, Large-Cell, Anaplastic
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib tablets and capsules.

Timeline

• Start date: 2011-09-20
• Primary completion: 2015-11-16
• Completion: 2020-02-18
• First posted: 2011-10-10
• Last updated: 2021-08-17
• Results posted: 2017-06-21

Regulatory

• FDA-regulated drug study