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

• Register: EUCTR
• Last refreshed on: 28 April 2014
• Main ID: EUCTR2011-005795-42-DE
• Date of registration: 17/02/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen Cilag International N.V.
• Public title: A Study of JNJ-40346527 in Patients with Relapsed or Refractory Hodgkin Lymphoma
• Scientific title: An Open-label, Multicenter Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin Lymphoma
• Date of first enrolment: 03/05/2012
• Target sample size: 68
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005795-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Dose escalation If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Germany, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Research & Development

• Name: Clinical Registry Group
• Affiliation: Janssen Research & Development

Key inclusion & exclusion criteria

Inclusion criteria:
1. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
1. Known brain metastases or leptomeningeal disease.
2.Other malignancy within past 5 years.
3.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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Subjects with Relapsed or Refractory Hodgkin’s Lymphoma
MedDRA version: 15.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864

Intervention(s)

Product Name: JNJ-40346527
Product Code: JNJ-40346527-AAC
Pharmaceutical Form: Capsule
Current Sponsor code: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: JNJ-40346527
Product Code: JNJ-40346527-AAC
Pharmaceutical Form: Capsule
Current Sponsor code: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: JNJ-40346527
Product Code: JNJ-40346527-AAC
Pharmaceutical Form: Capsule
Current Sponsor code: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: JNJ-40346527
Product Code: JNJ-40346527-AAC
Pharmaceutical Form: Capsule
Current Sponsor code: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: JNJ-40346527
Product Code: JNJ-40346527-AAC
Pharmaceutical Form: Capsule
Current Sponsor code: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Phase 1:
After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1.

Phase 2:
Up to 6 months after the last subject is enrolled.

Secondary Objective: Phase 1 and 2:
• To determine the safety profile of JNJ-40346527 in subjects with relapsed or refractory cHL.
• To determine the pharmacokinetics (PK) profile of JNJ-40346527 in subjects with relapsed or refractory cHL.
• To assess the effect of JNJ-40346527 on [18F]fluorodeoxyglucose(FDG)-positron emission tomography (PET) activity in subjects with relapsed or refractory cHL.
• To assess pharmacodynamic (PD) biomarkers of JNJ-40346527 in blood and tissue.
• To explore biomarkers predictive of response to JNJ-40346527.
• To explore PK/PD relationships with markers of pharmacological activity, efficacy, and treatment-emergent adverse events.

Phase 2:
•To determine the duration of response (DOR)
•To estimate progression-free survival (PFS)

Primary end point(s): Phase 1:
maximum tolerated dose (MTD) for JNJ-40346527.

Phase 2:
overall response rate.

Main Objective: Phase 1: To establish the recommended Phase 2 dose for JNJ-40346527.

Phase 2: To determine the overall response rate (complete response [CR] + partial response [PR]) in subjects with relapsed or refractory cHL.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Up to 6 months after the last subject is enrolled.
2. Up to 6 months after the last subject is enrolled.
3. Up to 30 days after the last dose of study medication.
4. Up to treatment cycle Day 21.
5. Up to treatment cycle Day 21.
6. Up to treatment cycle Day 21.
7. Up to treatment cycle Day 21.
8. Up to treatment cycle Day 21.
9. Up to treatment cycle Day 21.
10. Up to treatment cycle Day 21.

Secondary end point(s): 1. Duration of response (DOR)
2. Progression-free survival (PFS)
3. The number of participants affected by an adverse event.
4. Maximum observed plasma concentration of JNJ-40346527.
5. Trough plasma concentration of JNJ-40346527.
6. Minimum observed plasma concentration of JNJ-40346527.
7. Time of maximum observed plasma concentration of JNJ-40346527.
8. Area under the plasma concentration-time curve of JNJ-40346527.
9. Total drug clearance of JNJ-40346527.
10. Accumulation index of JNJ-40346527.

Secondary ID(s)

40346527HKL1001

Source(s) of Monetary Support

Janssen Research & Development LLC