Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-30979754/m2 · 1 trial · 1 indication
IWG response criteria (2000) - CR: bone marrow evaluations show \< 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.
| Arm | Type | Description |
|---|---|---|
| Phase I: JNJ-30979754 15 mg/m2 | EXPERIMENTAL | JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 |
| Phase I: JNJ-30979754 20 mg/m2 | EXPERIMENTAL | JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 |
| Phase II: JNJ-30979754 20 mg/m2 | EXPERIMENTAL | JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles |
| Name | Type | Description |
|---|---|---|
| JNJ-30979754 15 mg/m2 | DRUG | JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. |
| JNJ-30979754 20 mg/m2 | DRUG | Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants. |
Inclusion Criteria: * Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized French-American-British classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, c...
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JNJ-30979754/m2 is an investigational small molecule studied for the treatment of myelodysplastic syndrome, a group of bone marrow disorders in which blood cells do not form normally. It was evaluated in a Phase 1 trial conducted in Japan in patients with myelodysplastic syndrome.
JNJ-30979754/m2 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the clinical study of this asset in myelodysplastic syndrome.
JNJ-30979754/m2 is in Phase 1 development. It is investigational and has not been approved for commercial use. One Phase 1 trial has been completed, and no trials of this asset are currently listed as active.
JNJ-30979754/m2 was studied in one completed Phase 1 trial, NCT00796003, titled A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome. The trial enrolled 39 patients in Japan, included adults aged 20 years and older, and used a controlled design.