Clinical Trial Finder

Inclusion Criteria:

• - 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).

Exclusion Criteria:

• - 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.

• - Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).

• - Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing for viral hepatitis is not mandatory).

• - Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).

Arms

Experimental: Inflammatory myofibroblastic tumor (IMT)

Patients diagnosed with IMT with a confirmed translocation involving the ALK gene

Experimental: Anaplastic large cell lymphoma (ALCL)

Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive

Experimental: Glioblastoma (GBM)

Patients with GBM with a translocation involving the ALK gene

Experimental: Any other ALK-positive tumor

Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).

Interventions

Drug: - Ceritinib (LDK378)

Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.