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Also known as Dociparstat, Dociparstat sodium, CX-01, DSTAT, PGX-100
ODSH · 3 trials · 1 indication
Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
A primary endpoint of this study was evidence of an effect of dociparstat on transfusion independent platelet recovery time. The time (days) to transfusion-independent platelet recovery will be defined as the number of days from the first day of chemotherapy until the first of 5 consecutive days with platelet counts values ≥ 20,000/μL and ≥ 50,000/μL without a platelet transfusion.
| Arm | Type | Description |
|---|---|---|
| Control (idarubicin+cytarabine) | ACTIVE_COMPARATOR | Induction: * Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: * Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) |
| Dociparstat 0.125 mg/kg | EXPERIMENTAL | Induction: * Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7) * Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: * Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5) * Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: * Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours) * Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) |
| Dociparstat 0.25 mg/kg | EXPERIMENTAL | Induction: * Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7) * Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: * Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5) * Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2) * Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: * Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours) * Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) |
| Dociparstat | EXPERIMENTAL | The following induction regimen was administered: * Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days. * Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3. * Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days. |
| ODSH | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dociparstat sodium | DRUG | Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy. |
| Idarubicin | DRUG | Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy. |
| Cytarabine | DRUG | Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5. |
| ODSH | DRUG | - |
Inclusion Criteria: Subjects had to meet all the following criteria to be eligible for enrollment in this study: 1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML). 2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclu...
ODSH is an investigational small molecule being studied for use in Acute Myeloid Leukemia (AML). It was evaluated in a Phase 1 clinical trial in patients receiving induction or consolidation therapy for AML. The drug is still in clinical development and is not approved by the FDA.
ODSH is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical research on this investigational small molecule for the treatment of Acute Myeloid Leukemia.
ODSH is in Phase 1 clinical development. A Phase 1 trial, identified as NCT01843634, has been completed. This early-phase study evaluated the safety and efficacy of ODSH in patients with Acute Myeloid Leukemia. The drug remains investigational and has not received FDA approval.
ODSH has one completed clinical trial, NCT01843634, titled 'Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia'. This early Phase 1 study enrolled 10 participants in the United States and was not randomized or blinded.
ODSH is not known by any alternative names in the available information. It is a distinct investigational small molecule being developed by Jazz Pharmaceuticals for Acute Myeloid Leukemia. No other names for this drug have been reported.