Trials / Completed
CompletedNCT00791011
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
- Hodgkin's Lymphoma
- Low Grade Lymphoma
- Lymphoma
- Mantle Cell Lymphoma
- Non-Hodgkin's Lymphoma
- Diffuse Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 655 | AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5). |
| OTHER | Vorinostat | Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC). |
| OTHER | Bortezomib | A dipeptide boronic acid analogue with antineoplastic activity. |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2010-07-01
- Completion
- 2011-08-01
- First posted
- 2008-11-14
- Last updated
- 2014-03-05
Source: ClinicalTrials.gov record NCT00791011. Inclusion in this directory is not an endorsement.