Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) tumor other than Non-Small Cell Lung Cancer (NSCLC).
Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory.
Patient has WHO Performance Status (PS) ≤ 2
Patient must have received at least one line of prior systemic treatment for recurrent, locally advanced and/or metastatic disease, and may have discontinued for:
* Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM and by Cheson assessment criteria for lymphoma, or
* Intolerance described as any discontinuation due to an AE of any grade despite appropriate supportive treatment
Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
Patient has received no chemotherapy, immunotherapy or stem cell therapy at least 4 weeks before starting ceritinib
Radiotherapy and prior ALK inhibitors must be stopped at least 1 week prior to starting ceritinib
Recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03).
You may not be if
Patient has ALK+lung cancer
Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
Patient with acute or chronic GI disease that may significantly alter the absorption of ceritinib.
Patient with a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
