Ceritinib Rare Indications Study in ALK+ Tumors

NCT ID: NCT02465528

Last Updated: 2019-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-06
• Study Completion Date: 2018-08-20

Brief Summary

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).

Conditions

Tumors With Aberrations in ALK; Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumor; Glioblastoma

Keywords

ALK; GBM; hematological malignancy; anaplastic lymphoma kinase; glioblastoma; anaplastic large cell lymphoma; IMT; inflammatory myofibroblastic tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inflammatory myofibroblastic tumor (IMT)

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

Group Type: EXPERIMENTAL

Ceritinib (LDK378)

Intervention Type: DRUG

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.

Anaplastic large cell lymphoma (ALCL)

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

Group Type: EXPERIMENTAL

Ceritinib (LDK378)

Intervention Type: DRUG

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.

Glioblastoma (GBM)

Patients with GBM with a translocation involving the ALK gene

Group Type: EXPERIMENTAL

Ceritinib (LDK378)

Intervention Type: DRUG

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.

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).

Group Type: EXPERIMENTAL

Ceritinib (LDK378)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Brno, Czech Republic, Czechia

Novartis Investigative Site

Copenhagen, , Denmark

Novartis Investigative Site

Lyon, , France

Novartis Investigative Site

Saint-Herblain Cédex, , France

Novartis Investigative Site

Strasbourg, , France

Novartis Investigative Site

Tel Aviv, , Israel

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Bangkok, , Thailand

Countries

Belgium; Germany; Czechia; Denmark; France; Israel; Italy; South Korea; Spain; Thailand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLDK378A2407

Identifier Type: -

Identifier Source: org_study_id