Trials / Completed
CompletedNCT02835729
A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- NewLink Genetics Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idarubicin | Chemotherapy |
| DRUG | Cytarabine | Chemotherapy |
| DRUG | Indoximod Freebase | IDO pathway inhibitor |
| DRUG | Indoximod HCL F1 | IDO pathway inhibitor |
| DRUG | Indoximod HCL F2 | IDO pathway inhibitor |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2019-10-25
- Completion
- 2019-12-27
- First posted
- 2016-07-18
- Last updated
- 2020-06-04
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02835729. Inclusion in this directory is not an endorsement.