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Clinical Trial 19475

Cancer Type:
Interventions:Ceritinib (Zykadia)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Zeynep Eroglu

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 2 Study of Ceritinib in Patients with Unresectable Melanoma

Summary

The main purpose of this study is to determine the benefit of a drug named ceritinib (ZYKADIA) in patients who have progressed on prior melanoma therapy.

Objective

PRIMARY OBJECTIVE: To determine the overall response rate (ORR) of ceritinib (per RECIST 1.1 criteria). ORR will be defined by proportion of patients who have achieved a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.

Inclusion Criteria

  • Diagnosis of advanced/unresectable melanoma (AJCC v.8 Stage 3C/D/4).
  • Measurable disease, defined as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Must have at least one tumor site accessible for a biopsy.
  • Documented disease refractory to at least one PD1/PD-L1 (+/- CTLA-4) inhibitor treatment, or intolerance to these drugs.
  • If BRAFV600-mutant, refractory disease to at least one BRAF inhibitor and a MEK inhibitor (defined as progression while on treatment), or intolerance to these drugs.
  • Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline.
  • Prior radiation allowed.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 90 days after completion of ceritinib administration.
  • Participants must have normal organ and marrow function.

  • Exclusion Criteria

  • Potential participants with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate).
  • An untreated or uncontrolled brain metastases or evidence of leptomeningeal disease. Patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e., not requiring corticosteroids) at the time of study start will be eligible.
  • Previous malignancy is not an exclusion provided that the other malignancy is considered under control, patient is not on concomitant anti-cancer drug therapy, and target lesions from melanoma are clearly defined for response assessment.
  • Other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
  • Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).
  • A history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). (Note, this does NOT include immune-mediated pneumonitis).
  • A history of pancreatitis.
  • Impaired gastrointestinal (GI) function or GI disease that may alter absorption of ceritinib or inability to swallow.
  • Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to start of treatment with ceritinib and for the duration of participation: Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes; Strong inhibitors or strong inducers of CYP3A4/5, and Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9; Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban);Unstable or increasing doses of corticosteroids in the 5 days before first dose of study treatment;Enzyme-inducing anticonvulsive agents.