A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT03075826

Company

Weill Cornell Medicine

Contact Info

Tania Curcio, NP
Tjc9003@med.cornell.edu
212-746-2571

Dates

Start: March 2016
End: June 2019

Official Title

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

Purpose

Open label single-arm, single-institution study 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.

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Phase: 
Phase 2
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Participants must have confirmed diagnosis of Philadelphia chromosome negative MPN neoplasm based on WHO classification (reference) including Chronic Neutrophilic Leukemia (CNL), atypical Chronic Myeloid Leukemia (aCML), Chronic Myelomonocytic Leukemia (CMML), MPN/MDS overlap syndromes, accelerated phase myelofibrosis and MPN unclassifiable.
  • Age minimum of 18 years. Because no dosing or adverse event data are currently available on the use of SGI-110 in participants <18 years of age, children are excluded from this study but may be eligible for future pediatric trials.
  • ECOG performance status <3
  • Participants must have normal organ function as defined below:
    1. Total bilirubin < or = 1.5 x institutional upper limit of normal unless attributable to underlying disease, hemolysis or documented Gilbert’s syndrome.
    2. AST (SGOT)/ALT (SGPT) < 2.5 x institutional upper limit of normal unless attributable to underlying disease.
    3. Creatinine < 1.5 and or < or = 1.5 x institutional upper limit of normal or creatinine clearance add using Cockcroft Gault > 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
    4. LVEF < 40% is allowed as long as there is no NY class III/IV heart failure or uncontrolled arrhythmias.
  • The effects of SGI-110 on the developing human fetus are unknown. For this reason and because oncological agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria: 
  • Participants who have had any chemotherapy (investigational or FDA approved) (hydroxyurea is permitted) or radiotherapy within 2 weeks prior to study entry or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
  • Participants may not be treated with any other investigational agents while on this study unless approved by the principal investigator AND the sponsors of BOTH investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to decitabine or SGI-110.
  • Uncontrolled intercurrent illness including, but not limited to, infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because SGI-110 is a hypomethylating agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with SGI-110, breastfeeding should be discontinued.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Find Out More:

Disclaimer:

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any clinical trial listed on this website. Pharmaceutical company sponsored content is highlighted only to give additional information about the trial. All trials are listed on https://clinicaltrials.gov/. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a clinical trial, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.