Trials / Terminated
TerminatedNCT02109627
Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML
Phase Ib Study of Ficlatuzumab With High Dose Cytarabine (HiDAC) in Relapsed and Refractory AML
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- C. Babis Andreadis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ficlatuzumab | 5-20 mg/kg; intravenous; Days 0, 14, 28, and 42. Number of cycles: until progression or unacceptable toxicity develops. |
| DRUG | Cytarabine | 2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2019-12-02
- Completion
- 2019-12-02
- First posted
- 2014-04-10
- Last updated
- 2020-03-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02109627. Inclusion in this directory is not an endorsement.