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A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT ID: NCT01572519

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-17

Study Completion Date

2013-08-13

Brief Summary

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The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

Detailed Description

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This is an open-label (individuals will know the identity of study treatments), dose-escalation study to evaluate the clinical efficacy, safety, and pharmacokinetics (PK; study of what the body does to a drug) of JNJ-40346527. Up to 38 subjects could be enrolled in the Phase 1 portion of the study and up to 30 subjects could be enrolled in the Phase 2 portion of the study (although planned, the study did not move forward to the Phase 2 portion). During the Phase 1 portion of the study, dose escalation of JNJ-40346527 will start at 150 mg (Cohort 1) once daily up to the maximum tolerated dose (MTD) or the highest planned dose (600 mg once daily); twice daily dosing may also be performed if deemed necessary. A Study Evaluation Team (SET) will review all available data after 1 cycle (21 days) of treatment for each cohort before any additional dose escalation occurs and will also determine the recommended Phase 2 dose for the expansion cohort. This study will consist of 3 periods: a screening period (from signing of informed consent until immediately before dosing), an open-label treatment period (from the first dose of study drug until the end-of-treatment visit), and a follow-up period (after the end-of-treatment visit). All patients will participate in the screening and treatment period. Patients will be administered JNJ-40346527 continuously until disease progression, or unacceptable toxicity (based on investigator assessment). The National Cancer Institute-Common Terminology Criteria for Adverse Events will be used to grade toxicity throughout the study. Disease response will be assessed according to the Revised Response Criteria for Malignant Lymphoma. Treatment will continue until disease progression or unacceptable toxicity (based on investigator assessment) occurs. Only patients who discontinue study drug before disease progression or discontinue due to treatment-related Grade 3 or higher toxicity will continue in the follow-up period. Serial PK samples will be collected in Cycle 1 as detailed in the protocol. Safety will be monitored throughout the study.

Conditions

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Relapsed or Refractory Hodgkin Lymphoma

Keywords

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Relapsed Hodgkin lymphoma Refractory Hodgkin lymphoma JNJ-40346527 Dose-escalation Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-40346527

Group Type EXPERIMENTAL

Phase 1, Cohort 1

Intervention Type DRUG

Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 2

Intervention Type DRUG

Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 3

Intervention Type DRUG

Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 4

Intervention Type DRUG

Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.

Phase 2

Intervention Type DRUG

JNJ-40346527 at the recommended dose determined in Phase 1

Interventions

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Phase 1, Cohort 1

Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.

Intervention Type DRUG

Phase 1, Cohort 2

Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.

Intervention Type DRUG

Phase 1, Cohort 3

Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.

Intervention Type DRUG

Phase 1, Cohort 4

Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.

Intervention Type DRUG

Phase 2

JNJ-40346527 at the recommended dose determined in Phase 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Patients with histopathologically confirmed initial diagnosis of Hodgkin lymphoma and who have disease that has relapsed or is refractory that is progressing or active and requires treatment after at least 1 appropriate therapy

Exclusion Criteria

* Known brain metastases or leptomeningeal disease
* Other malignancy within past 5 years
* Has any condition that, in the opinion of the investigator, would make study participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
* QTc prolongation at screening or other factors that increase the risk of QT prolongation such as diagnosis or family history of long-QT syndrome, diagnosed or suspected congenital long QT syndrome, or concomitant use of medication that can prolong the QT interval
* Taking CYP3A4 substrate drugs with a narrow therapeutic index (eg, alfentanil, astemizole, sirolimus, tacrolimus, terfenadine)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Lille, , France

Site Status

Villejuif, , France

Site Status

Cologne, , Germany

Site Status

Würzburg, , Germany

Site Status

Countries

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United States France Germany

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005795-42/results

Link to results on EudraCT registry

Other Identifiers

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40346527HKL1001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005795-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100813

Identifier Type: -

Identifier Source: org_study_id