Trials / Terminated
TerminatedNCT01370694
Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.
Detailed description
The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-8808 | |
| DRUG | cyclophosphamide | |
| DRUG | vincristine | |
| DRUG | prednisolone |
Timeline
- Start date
- 2011-08-19
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2011-06-10
- Last updated
- 2019-03-15
- Results posted
- 2015-11-25
Source: ClinicalTrials.gov record NCT01370694. Inclusion in this directory is not an endorsement.