Clinical Trials /

Ceritinib Rare Indications Study in ALK+ Tumors

NCT02465528

Description:

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).

Related Conditions:
  • Cancer
  • Malignant Neoplasm
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ceritinib Rare Indications Study in ALK+ Tumors
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: CLDK378A2407
  • NCT ID: NCT02465528

Conditions

  • Tumors With Aberrations in ALK

Interventions

DrugSynonymsArms
Ceritinib (LDK378)Ceritinib (LDK378)

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Ceritinib (LDK378)Experimental
  • Ceritinib (LDK378)

Eligibility Criteria

        Inclusion Criteria:

          -  Patient has a histologically or cytologically confirmed diagnosis of ALK positive
             (ALK+) 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, 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

               -  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.

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Control Rate (DCR) based on local assessments
Time Frame:16 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Baseline , every 8 weeks until disease progression or end of treatment. whichever came first assessed upto 24 months.
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Baseline, every 8 weeks until disease progression or end of treatement, whichever came first assessed upto 24 months.
Safety Issue:
Description:
Measure:Time to Response (TTR)
Time Frame:Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed upto 24 months.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • ALK
  • NSCLC
  • hematological malignancy

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