NCT02465528 · REGISTRY CONDITION SEARCH

Ceritinib Rare Indications Study in ALK+ Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2019-12-27

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Overall Response Rate (ORR) Per Investigator Assessment

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outcome · POSTED

Duration of Response (DOR) Per Investigator Assessment

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outcome · POSTED

Time to Response (TTR) Per Investigator Assessment

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outcome · POSTED

Progression Free Survival (PFS) Per Investigator Assessments

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outcome · POSTED

Percent of Participant Deaths During Treatment and Follow-up

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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).
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
intervention Names
Drug: Ceritinib (LDK378)
label
Inflammatory myofibroblastic tumor (IMT)
type
EXPERIMENTAL
description
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
intervention Names
Drug: Ceritinib (LDK378)
label
Anaplastic large cell lymphoma (ALCL)
type
EXPERIMENTAL
description
Patients with GBM with a translocation involving the ALK gene
intervention Names
Drug: Ceritinib (LDK378)
label
Glioblastoma (GBM)
type
EXPERIMENTAL
description
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
intervention Names
Drug: Ceritinib (LDK378)
label
Any other ALK-positive tumor
type
EXPERIMENTAL

interventions

arm Group Labels
Anaplastic large cell lymphoma (ALCL)
Any other ALK-positive tumor
Glioblastoma (GBM)
Inflammatory myofibroblastic tumor (IMT)
description
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.
name
Ceritinib (LDK378)
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

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.

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 22
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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).
measure
Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
time Frame
Baseline up to approximately 16 weeks

secondary Outcomes

description
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.
measure
Overall Response Rate (ORR) Per Investigator Assessment
time Frame
Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks
description
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
measure
Duration of Response (DOR) Per Investigator Assessment
time Frame
Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
description
TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
measure
Time to Response (TTR) Per Investigator Assessment
time Frame
Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
description
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
measure
Progression Free Survival (PFS) Per Investigator Assessments
time Frame
Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks
description
Deaths due to any cause during treatment and 30 day follow-up
measure
Percent of Participant Deaths During Treatment and Follow-up
time Frame
Baseline up to approximately 84 weeks

Full study description

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).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice