Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zosuquidar trihydrochloride · 1 trial · 2 indications
Time from randomization to death. Patients alive at last follow-up were censored.
| Arm | Type | Description |
|---|---|---|
| Zosuquidar | EXPERIMENTAL | Induction treatment with daunorubicin, cytarabine and zosuquidar (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. |
| Placebo | ACTIVE_COMPARATOR | Induction treatment with daunorubicin, cytarabine and placebo (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. |
| Name | Type | Description |
|---|---|---|
| filgrastim | BIOLOGICAL | 250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. |
| sargramostim | BIOLOGICAL | 5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. |
| cytarabine | DRUG | 100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7). |
| daunorubicin hydrochloride | DRUG | 45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3). |
| zosuquidar trihydrochloride | DRUG | Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. |
| Placebo | DRUG | Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored. |
Inclusion Criteria: One of the following disorders: * Acute myeloid leukemia (AML), defined as \>30% myeloblasts on the marrow aspirate or peripheral blood differential and any French-American-British (FAB) subtype except M3 (i.e., acute promyelocytic leukemia) * Refractory anemia with excess blas...
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