Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Glioblastoma

Congenital Abnormalities

Lymphoma

Hematologic Neoplasms

Lymphoma, Large-Cell, Anaplastic

Granuloma

Granuloma, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Inflammatory Myofibroblastic Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Ceritinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

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

Patients with GBM with a translocation involving the ALK gene

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

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.

Ceritinib (LDK378)

This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).

Depending on the tumor type, subjects were to be enrolled into one of the following parallel arms: ALCL (anaplastic large cell lymphoma); IMT (inflammatory myofibroblastic tumor); glioblastoma (GBM), and any other ALK+ tumor. If there were 5 or more subjects of the same tumor type in the "Any other ALK+ tumor" arm, then a separate arm was to be opened for that specific tumor type.

Ceritinib Rare Indications Study in ALK+ Tumors

A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)

The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).

ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.

DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause

TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)

PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause

Deaths due to any cause during treatment and 30 day follow-up

Novartis Pharmaceuticals

Any sign or symptom that occured during the study treatment plus 30 days post treatment

Any Other ALK+ Tumor

All Subjects

Anaplastic Large Cell Lymphoma (ALCL)

Inflammatory Myofibroblastic Tumor (IMT)

Glioblastoma (GBM)

Any Other ALK-positive Tumor

Total

Age, Continuous

18 to <65

65 to <=75

Age, Customized

Sex: Female, Male

Caucasian

Asian

Other

Race/Ethnicity, Customized

Study Director

Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment

Spots Global Cancer Trial Database for Ceritinib Rare Indications Study in ALK+ Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial