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 being studied for the treatment of Myelodysplastic Syndrome (MDS), a type of blood cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JNJ-30979754/m2 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Myelodysplastic Syndrome.
JNJ-30979754/m2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of Myelodysplastic Syndrome.
JNJ-30979754/m2 has one completed clinical trial, NCT00796003, which was a Phase 1 study in patients with Myelodysplastic Syndrome. The trial enrolled 39 participants and was conducted in Japan. No active trials are currently listed for this drug.
The clinical trial NCT00796003 refers to JNJ-30979754 as decitabine, indicating that JNJ-30979754/m2 is also known by this name. Decitabine is a nucleoside metabolic inhibitor used in the treatment of myelodysplastic syndromes.