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Relapsed or Refractory Hodgkin LymphomaPhase 1NCT01572519

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

A Phase 1 study testing Phase 1, Cohort 1, Phase 1, Cohort 2 and Phase 1, Cohort 3 in people with Relapsed or Refractory Hodgkin Lymphoma, run by Janssen Research & Development, LLC at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Hodgkin Lymphoma
What is being tested?
Phase 1, Cohort 1, Phase 1, Cohort 2 and Phase 1, Cohort 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesin 2 countries
Study dates
17 Jul 2012to 13 Aug 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France2 sites

  • Study site

    Lille

  • Study site

    Villejuif

Other trials in France

Germany2 sites

  • Study site

    Cologne

  • Study site

    Würzburg

Other trials in Germany

About this study

Official title: An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

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.

Read the detailed description

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.

Being tested
Phase 1, Cohort 1, Phase 1, Cohort 2, Phase 1, Cohort 3, Phase 1, Cohort 4, Phase 2
Keywords
Relapsed Hodgkin lymphoma, Refractory Hodgkin lymphoma, JNJ-40346527, Dose-escalation, Pharmacokinetics
Medical subject headings
Recurrence, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase 1, Cohort 1Drug

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

  • Phase 1, Cohort 2Drug

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

  • Phase 1, Cohort 3Drug

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

  • Phase 1, Cohort 4Drug

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

  • Phase 2Drug

    JNJ-40346527 at the recommended dose determined in Phase 1

Study groups in NCT01572519
Study groupRoleWhat they receive
JNJ-40346527ExperimentalNot described
Receives: Drug: Phase 1, Cohort 1; Drug: Phase 1, Cohort 2; Drug: Phase 1, Cohort 3; Drug: Phase 1, Cohort 4; Drug: Phase 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Phase 2 overall response rate

    Measured: Up to 6 months after the last subject is enrolled

Secondary outcomes (10)

  1. Duration of response (DOR)

    Measured: Up to 6 months after the last subject is enrolled

  2. Progression-free survival (PFS)

    Measured: Up to 6 months after the last subject is enrolled

  3. The number of participants affected by an adverse event

    Measured: Up to 30 days after the last dose of study medication

  4. Maximum observed plasma concentration of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  5. Trough plasma concentration of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  6. Minimum observed plasma concentration of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  7. Time of maximum observed plasma concentration of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  8. Area under the plasma concentration-time curve of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  9. Total drug clearance of JNJ-40346527

    Measured: Up to treatment cycle Day 21

  10. Accumulation index of JNJ-40346527

    Measured: Up to treatment cycle Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2012 (estimated)
  2. Study start17 Jul 2012
  3. Primary completion13 Aug 2013
  4. Study completion13 Aug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572519
Sponsor's protocol ID
CR100813
Other IDs
40346527HKL1001, 2011-005795-42
Status last verified
Nov 2020
First submitted
16 Feb 2012
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Phase 1, Cohort 1, Phase 1, Cohort 2 and Phase 1, Cohort 3 in people with Relapsed or Refractory Hodgkin Lymphoma, run by Janssen Research & Development, LLC at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 maximum tolerated dose (MTD) for JNJ-40346527 (time frame: After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.

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