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Hodgkin's LymphomaPhase 1NCT00791011

Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat

A Phase 1 study testing AMG 655, Vorinostat and Bortezomib in people with Hodgkin's Lymphoma and Low Grade Lymphoma, run by Amgen.

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

This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma, Low Grade Lymphoma, Lymphoma
What is being tested?
AMG 655, Vorinostat and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Feb 2008to Aug 2011
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

  • Part 1: Subjects must have a pathologically confirmed diagnosis of lymphoma that is relapsed or refractory to standard treatment or for which no curative therapy is available. Lymphoma subtypes that are eligible for enrollment include low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease.
  • Part 2: Subjects must have relapsed or refractory mantle cell lymphoma with at least one objective measurable disease site (ie, measurable in at least 2 perpendicular parameters). Subjects must have had at least one prior antineoplastic therapy, up to a maximum of 3. At least one therapy must have included an anthracycline. Subjects must have had documented relapse or progression following the last therapy (ie, most recent therapy given prior to enrollment). An abnormal PET scan will not constitute evaluable disease, unless verified by CT or MRI scan).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal, hepatic and coagulation function

Who cannot join

  • A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
  • A history of allogeneic stem-cell transplantation
  • Primary central nervous system (CNS) tumors including primary CNS lymphoma
  • Central nervous system involvement by lymphoma
  • Myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association >class II), unstable angina, or unstable cardiac arrhythmia requiring medication
  • Vorinostat cohorts only: History of significant GI surgery or disease, which would impair intestinal absorption
Show all 10Show fewer
  • Vorinostat cohorts only: Active peptic ulcer disease
  • Prior exposure to AMG 655 or other investigational TRAIL receptor agonists is not permitted
  • Prior treatment with bortezomib or vorinostat is not permitted for subjects enrolling in the bortezomib and vorinostat cohorts, respectively
  • Major surgery within 28 days before the first dose of AMG 655

About this study

Official title: A Phase 1b Study to Evaluate the Safety and Tolerability of AMG 655 in Combination With Bortezomib or Vorinostat in Subjects With Relapsed or Refractory Lymphoma

This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease.

Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or vorinostat. Subjects will be enrolled into one of two arms based on investigator selection (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).

Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG 655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in combination with bortezomib will be based on safety and pharmacokinetic information obtained from Part 1 as well as from ongoing AMG 655 trials.

Being tested
AMG 655, Vorinostat, Bortezomib
Keywords
Lymphoma, AMG 655, Trail receptor, Apoptosis, Vorinostat, Bortezomib, SAHA, Velcade
Medical subject headings
Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • AMG 655Drug

    AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).

  • VorinostatOther

    Also called SAHA

    Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).

  • BortezomibOther

    Also called Velcade

    A dipeptide boronic acid analogue with antineoplastic activity.

Study groups in NCT00791011
Study groupRoleWhat they receive
Cohort 4ExperimentalAMG 655 (intermediate dose) with Vorinostat
Receives: Drug: AMG 655; Other: Vorinostat
Cohort 1ExperimentalAMG 655 (low dose) with Bortezomib
Receives: Drug: AMG 655; Other: Bortezomib
Cohort 2ExperimentalAMG 655 (low dose) with vorinostat
Receives: Drug: AMG 655; Other: Vorinostat
Cohort 5ExperimentalAMG 655 (high dose) with Bortezomib
Receives: Drug: AMG 655; Other: Bortezomib
Cohort 6ExperimentalAMG 655 (high dose) with Vorinostat
Receives: Drug: AMG 655; Other: Vorinostat
Cohort 7ExperimentalPart 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib
Receives: Drug: AMG 655; Other: Bortezomib
Cohort 3ExperimentalAMG 655 (intermediate dose) with Bortezomib
Receives: Drug: AMG 655; Other: Bortezomib

What is being measured

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

  1. Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs.

    Measured: Length of Study

  2. Part 2: Objective response rate of AMG 655 Therapy as determined by using IWG criteria at the dose selected in Part 1, in combination with Bortezomib in subjects with mantle cell lymphoma

    Measured: Length of Study

Secondary outcomes (9)

  1. Part 2: Overall survival (OS).

    Measured: Length of study.

  2. Part 2: Progression-Free Survival (PFS).

    Measured: Length of treatment phase.

  3. Part 2: PK parameters for AMG 655 on a 3 week dosing schedule.

    Measured: Treatment and follow up phase of study.

  4. Part 2: Subject incidence of anti-AMG 655 antibody formation.

    Measured: Treatment and follow up phase of study.

  5. Part 2: Duration of response.

    Measured: Length of treatment phase.

  6. Part 1: Subject incidence of anti-AMG 655 antibody formation.

    Measured: Treatment and follow up phase of study.

  7. Part 1: Best tumor response, objective response rate and duration of response.

    Measured: Length of treatment phase.

  8. Part 1: Maximum tolerated dose of AMG 655 administered with bortezomib or vorinostat, if reached.

    Measured: First 21 days of treatment for each cohort.

  9. Part 1: PK parameters for AMG 655 on a 3 week dosing schedule.

    Measured: Treatment and follow up phase of study.

Timeline

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

  1. First posted14 Nov 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2010
  4. Study completionAug 2011

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00791011
Sponsor's protocol ID
20060340
Status last verified
Mar 2014
First submitted
13 Nov 2008
Last updated
5 Mar 2014
Results posted
No

Publications

  • Younes A, Sokol L, Ribeiro de Oliveira M, Popplewell L, Romaguera JE, Copeland A, Sabin T, Hsu CP, Pan Y, Gorski K, Hwang Y, Wong S, Beaupre D, Kirschbaum MH.A Phase 1b Study Simultaneously Evaluating Two Novel Conatumumab-Based Combinations in Patients With Relapsed or Refractory Lymphoma.Journal-001239;

  • Younes A, Sokol L, Ribeiro de Oliveira M, Popplewell L, Romaguera JE, Copeland A, Sabin T, Hsu CP, Pan Y, Gorski K, Hwang Y, Wong S, Beaupre D, Kirschbaum MH.A Phase 1b Study Simultaneously Evaluating Two Novel Conatumumab-Based Combinations in Patients With Relapsed or Refractory Lymphoma.Journal-004521;

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 655, Vorinostat and Bortezomib in people with Hodgkin's Lymphoma and Low Grade Lymphoma, run by Amgen.

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 4 inclusion and 10 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 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs. (time frame: Length of Study). 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 NCT00791011, which also lists 2 linked publications.

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 5 Mar 2014.

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