Moving AP26113 forward.
ARIAD announced the start of an international Phase 1/2 clinical trial of AP26113 in September 2011. Read the Press Release. The initial Phase 1 dose-escalation portion includes patients with advanced solid tumors, particularly those with NSCLC. Patients enrolled in this multi-center study will be either refractory to available therapies or have no standard treatment available to them. The primary objective of the Phase 1 segment of the Phase 1/2 trial is to determine the initial safety, tolerability, pharmacokinetic profile, recommended dose (anticipated to be once daily) and preliminary anti-tumor activity of AP26113. ARIAD expects to enroll approximately 50 to 60 patients in this portion of the trial.
The trial is currently enrolling patients and ARIAD presented initial proof-of-concept at the ESMO 2012 Meeting. Read the Press Release.
The Phase 2 part of the trial is expected to begin in the second half of 2013 and is currently planned to include five genetically defined patient cohorts, including:
Patients with ALK positive NSCLC who have not previously received an ALK inhibitor Patients with ALK positive NSCLC who are resistant to at least one ALK inhibitor Patients with EGFR positive NSCLC who are resistant to at least one prior EGFR inhibitor Patients with other cancers expressing ALK or other known targets of AP26113 Patients with ALK-positive NSCLC who also have brain metastases The Phase 2 trial is planned to enroll approximately 80 patients and will provide further data on the preliminary anti-tumor activity of AP26113 in these molecularly defined patient populations. |