Clinical trial · Interventional
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma
NCT01572519CI-TRIAL-00048400completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase 1, Cohort 1 | Drug | — | UNRESOLVED |
| Phase 1, Cohort 2 | Drug | — | UNRESOLVED |
| Phase 1, Cohort 3 | Drug | — | UNRESOLVED |
| Phase 1, Cohort 4 | Drug | — | UNRESOLVED |
| Phase 2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JNJ-40346527
- interventionNames
- Drug: Phase 1, Cohort 1
- Drug: Phase 1, Cohort 2
- Drug: Phase 1, Cohort 3
- Drug: Phase 1, Cohort 4
- Drug: Phase 2
Primary outcomes (2)
- measure
- Phase 1 maximum tolerated dose (MTD) for JNJ-40346527
- timeFrame
- After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1
- measure
- Phase 2 overall response rate
- timeFrame
- Up to 6 months after the last subject is enrolled
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.