IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome
NCT03175978 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2024-05-21
Summary
The primary objective of this study is to determine the safety and tolerability of utilizing the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of advanced, previously treated myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML), including determining the maximum tolerated dose (MTD).
Conditions
- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic
- Anemia, Refractory, With Excess of Blasts
Interventions
- DRUG
-
IGF/MTX
765IGF-MTX is supplied as a 5 ml sterile solution at 4.0 µeq per ml 765IGF-MTX concentration in aqueous 10 mM HCl in a 10 ml glass vial
Sponsors & Collaborators
-
IGF Oncology, LLC
lead INDUSTRY
Principal Investigators
-
Mrinal S Patniak · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-21
- Primary Completion
- 2021-06-30
- Completion
- 2021-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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