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Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

NCT02907359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2024-08-27

Study results available
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Summary

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

Conditions

Interventions

DRUG

Guadecitabine

OTHER

Treatment Choice

* BSC: according to standard/institutional practice; included RBC or platelet transfusions; growth factors, i.e. erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy; broad spectrum antibiotics and/or antifungals. * LDAC: 20 mg/m\^2 SC or IV once daily (QD) for 14 days in 28-day cycles. Other schedules were allowed per institutional practice. Treatment for ≥4 cycles absent disease progression/toxicity. BSC per institutional/standard practice. * Standard Intensive Chemotherapy: recommended regimen of 7+3 was given as cytarabine 100-200 mg/m\^2/day continuous infusion for 7 days and an anthracycline for 3 days. Anthracyclines per institutional practice included daunorubicin (45-60 mg/m\^2/day) or idarubicin (9-12 mg/m\^2/day) or mitoxantrone (8-12 mg/m\^2/day) by IV infusion. Participants with complete or partial response after IC induction received ≥1 additional cycles with reduced cytotoxic doses then BSC per standard /institutional practice.

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Yuri Sano, MD, PhD · Astex Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-13
Primary Completion
2020-03-31
Completion
2020-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02907359 on ClinicalTrials.gov