A Phase 1/2 Study of the Oral ALK/EGFR Inhibitor AP26113
Conditions
Advanced Malignancies | Anaplastic Large Cell Lymphoma | Carcinoma, Non-Small-Cell Lung | Diffuse Large Cell Lymphoma | Inflammatory Myofibroblastic Tumors
What is the purpose of this trial?
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 AP26113, 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 AP26113, both in non-small cell lung cancer (NSCLC) with ALK gene rearrangement or mutated EGFR, and in other cancers with abnormal targets against which AP26113 is active. Approximately 110 to 130 patients will be enrolled.
Participation Guidelines
- Age:
- 18 Years and older
- Gender:
- Both
Click here for detailed information about who can participate in this trial.
- Sponsor:
- Ariad Pharmaceuticals
- Dates:
- September 2011
- Last Updated:
- January 7, 2013
- Study HIC#:
- 1108008891
Clinicaltrials.gov ID: NCT01449461




