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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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Zosuquidar trihydrochloride is an investigational small molecule developed by Eli Lilly and Company for use in leukemia. It was studied as an add-on to standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia or refractory anemia. It is a Phase 3 candidate and has not been approved by the FDA.
Zosuquidar trihydrochloride was studied in older patients with newly diagnosed acute myeloid leukemia or refractory anemia, where it was added to daunorubicin and cytarabine chemotherapy. The Phase 3 trial enrolled patients aged 60 years and older. It remains an investigational agent rather than an approved leukemia treatment.
Zosuquidar trihydrochloride targets ABCB1, also known as P-glycoprotein, and acts as an inhibitor of that transporter. By blocking ABCB1, the drug is designed to interfere with the efflux pump that can move chemotherapy agents out of leukemia cells, a mechanism studied in combination with daunorubicin and cytarabine.
Zosuquidar trihydrochloride is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 3 study of the agent in older patients with acute myeloid leukemia or refractory anemia.
Zosuquidar trihydrochloride reached Phase 3 development. The single registered trial, NCT00046930, is a completed Phase 3 study that randomized 449 patients and used an active-controlled, double-blind design. The drug is investigational and has not been approved by the FDA.
Zosuquidar trihydrochloride was evaluated in one registered clinical trial, NCT00046930, titled Daunorubicin and Cytarabine With or Without Zosuquidar in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia. That Phase 3 study is completed, enrolled 449 patients, and ran in the United States and Israel.