Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML
NCT02875093 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2020-03-05
Summary
Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease
Conditions
Interventions
- DRUG
-
ADI-PEG 20
Investigational Medicine
- DRUG
-
low-dose cytarabine 20 mg BID twice daily for 10 days, every 28 days
Sponsors & Collaborators
-
Polaris Group
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-20
- Primary Completion
- 2019-07-10
- Completion
- 2019-07-10
- FDA Drug
- Yes
Countries
- Taiwan
Study Locations
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