NCT01572519

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2013

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

February 16, 2012

Last Update Submit

November 18, 2020

Conditions

Relapsed or Refractory Hodgkin Lymphoma

Keywords

Relapsed Hodgkin lymphomaRefractory Hodgkin lymphomaJNJ-40346527Dose-escalationPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Phase 1 maximum tolerated dose (MTD) for JNJ-40346527

    After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1

  • Phase 2 overall response rate

    Up to 6 months after the last subject is enrolled

Secondary Outcomes (10)

  • Duration of response (DOR)

    Up to 6 months after the last subject is enrolled

  • Progression-free survival (PFS)

    Up to 6 months after the last subject is enrolled

  • The number of participants affected by an adverse event

    Up to 30 days after the last dose of study medication

  • Maximum observed plasma concentration of JNJ-40346527

    Up to treatment cycle Day 21

  • Trough plasma concentration of JNJ-40346527

    Up to treatment cycle Day 21

  • +5 more secondary outcomes

Study Arms (1)

JNJ-40346527

EXPERIMENTAL
Drug: Phase 1, Cohort 1Drug: Phase 1, Cohort 2Drug: Phase 1, Cohort 3Drug: Phase 1, Cohort 4Drug: Phase 2

Interventions

Phase 1, Cohort 1DRUG

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

JNJ-40346527
Phase 1, Cohort 2DRUG

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

JNJ-40346527
Phase 1, Cohort 3DRUG

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

JNJ-40346527
Phase 1, Cohort 4DRUG

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

JNJ-40346527
Phase 2DRUG

JNJ-40346527 at the recommended dose determined in Phase 1

JNJ-40346527

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Lille, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Related Links

MeSH Terms

Conditions

RecurrenceHodgkin Disease

Interventions

Clinical Trials, Phase I as TopicClinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

April 6, 2012

Study Start

July 17, 2012

Primary Completion

August 13, 2013

Study Completion

August 13, 2013

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

DE(2)FR(2)