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Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

About

Brief Summary

Imetelstat (JNJ-63935937) is a telomerase inhibitor. This is an experimental drug that blocks an enzyme (a type of protein) involved in the increase in the number of cancer cells. Blocking this enzyme may be a very important mechanism in killing cancer cells. In this study, imetelstat is tested to see how useful it is in patients with myelodysplastic syndrome. \n\n Patients will have physical exams, Electrocardiograms (measurements of the heart activity), bone marrow biopsy, blood collection for routine tests and to see how he drug is affecting the patient s body and how the body processes the drug. Blood samples will also be collected for genetic research.\n\n Patients will come in on the screening day and on days 1, 8, 15 and 22 of cycle 1. They will come back for days 1, 8, 15, 22 of cycle 2. They will come back once per month starting on cycle 3 and continuing for as long as the patient is deriving benefit from the drug. It is anticipated that patients will stay on treatment for about 2 years after the last patient is enrolled. Patients will have an end of treatment visit about 30 days after their last dose. After their end of treatment visit, the patients will be followed for survival every 16 weeks.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects diagnosed with low or intermediate risk Myelodysplastic Syndrome \n\n For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

  • Man or woman greater than or equal to (>=) 18 years of age
  • In Part 1, diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria
  • International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
  • Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

  • Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
  • Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
  • Prior treatment with imetelstat
  • Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
  • a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide; c) Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)

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Study Stats
Protocol No.
15-001804
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02598661
For detailed technical eligibility, visit ClinicalTrials.gov.