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Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies

NCT02343679 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-02-01

No results posted yet for this study

Summary

This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least one dose of study drug will be evaluable for safety. Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response. Each subject will receive the same dose of 750mg po daily at the study entry. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision. Intrapatient dose reductions will be allowed for adverse events. This is a multicenter study with Duke as the lead site. Blood and tissue samples, will be collected and used for exploratory analysis.

Conditions

Interventions

DRUG

ceritinib

Ceritinib will be administered to ALK + hematologic malignancies orally at the 750mg/day dose that has been calculated as the maximum tolerated dose in prior phase I trials in lung cancer patients. Intra patient dose reductions will be allowed for toxicities. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician choice.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Anne Beaven, MD

    lead OTHER

Principal Investigators

  • Anne Beaven, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-10-31
Completion
2022-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343679 on ClinicalTrials.gov