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A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms

NCT03075826 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-05-05

Study results available
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Summary

* This is an open label single-arm, single-institution stud to evaluate the efficacy and safety of SGI-110 in Philadelphia chromosome negative (Ph-) Myeloproliferative Neoplasms (MPN) (excluding PV, ET and primary/secondary myelofibrosis). The study will enroll approximately 50 patients at the Weill Cornell Medical College.
* Enrollment onto this clinical study is expected to be completed in approximately 36 months. The total study duration will depend on individual response, evidence of disease progression and tolerance. Participants will be followed monthly for six months after removal from study or until death, whichever occurs first.

Key eligibility:

* Confirmed diagnosis of Ph- MPN and had
* No chemotherapy or radiation treatment within 2 weeks prior to study entry.
* Subjects meet other protocol-defined criteria related to baseline screening procedures.

Conditions

  • Myeloproliferative Neoplasms

Interventions

DRUG

SGI-110

subcutaneously at a dose of 60 mg/m2

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Pinkal Desai, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075826 on ClinicalTrials.gov