Trials / Terminated
TerminatedNCT03834584
A Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma
A Phase 1 Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Agios Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-636, an oral Dihydroorotate Dehydrogenase (DHODH) inhibitor, in subjects with advanced lymphoma.
Detailed description
The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-636 and characterize its dose-limiting toxicities (DLTs) when given by mouth to subjects with advanced lymphoma that is refractory to standard treatment. During the dose escalation part of the study successive cohorts of subjects will be treated with increasing doses of AG-636 in order to determine its maximum tolerated dose (MTD). Subsequently, in the dose expansion part of the study, additional subjects will be treated at the MTD in order to confirm that dose's safety, tolerability, PK and PD, and to provide an opportunity to detect anti-lymphoma activity. The dose expansion part of the study will support the selection of a dose for future clinical studies (a recommended Phase 2 dose \[RP2D\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AG-636 | AG-636 will be administered orally intermittently in 28-day cycles. |
Timeline
- Start date
- 2019-05-24
- Primary completion
- 2020-06-17
- Completion
- 2020-06-17
- First posted
- 2019-02-08
- Last updated
- 2020-08-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03834584. Inclusion in this directory is not an endorsement.