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.
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|Sponsor:||Ariad Pharmaceuticals Inc.|
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