A Phase 1/2 Study of the Oral ALK/EGFR Inhibitor AP26113

Diseases and Conditions Researched

Anus; Bladder; Bones and Joints; Brain and Nervous System; Breast - Female; Breast - Male; Cervix Uteri; Colon; Corpus Uteri; Esophagus; Eye and Orbit; Hodgkin's Lymphoma; Ill-Defined Sites; Kidney; Larynx; Lip, Oral Cavity and Pharynx; Liver; Lung; Lung Cancer; Melanoma, skin; Multiple Myeloma; Non-Hodgkin's Lymphoma; Other Digestive Organ; Other Endocrine System; Other Female Genital; Other Male Genital; Other Urinary; Ovary; Pancreas; Prostate; Rectum; Small Intestine; Soft Tissue; Stomach; Thyroid

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 participation information for this trial.

Sponsor: Ariad Pharmaceuticals Inc.
Dates:
Last Updated:
Study HIC#: 1108008891