Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as omacetaxine, Homoharringtonine, HHT, Synribo, OMA, CGX-635
omacetaxine mepesuccinate · 4 trials · 4 indications
Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses. Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last \>= 8 weeks to be considered meaningful. Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy.
Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses. Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available. Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows \>0% - 35% Ph+ cells. Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy.
TEAE are any untoward events that were newly occurring or worsening from Baseline. Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. A participant is only counted once in each category (at worst severity or strongest relationship).
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
| Arm | Type | Description |
|---|---|---|
| OMA | EXPERIMENTAL | Omacetaxine mepesuccinate (OMA) Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days for up to six cycles. Omacetaxine mepesuccinate (OMA) Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days for up to 24 months. |
| omacetaxine | EXPERIMENTAL | Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years. |
| Homoharringtonine | EXPERIMENTAL | - |
| omacetaxine mepesuccinate | EXPERIMENTAL | Period A: 7-day pharmacokinetic assessment period in which all patients will be administered a single subcutaneous radiolabeled dose of 1.25-mg/m2 omacetaxine. Period B: omacetaxine will be administered as an sc injection at a dosage of 1.25 mg/m2 twice daily for 7 days (patients with solid tumors) or 14 days (patients with hematologic malignancies) of every 28-day cycle for up to 6 cycles. |
| Name | Type | Description |
|---|---|---|
| Omacetaxine mepesuccinate | DRUG | Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days. Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days. Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study. |
| Omacetaxine | DRUG | 1.25 mg/m2 subcutaneous twice daily for 14 days |
Inclusion Criteria: * Male or female patients, age 18 years or older * Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase * Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, t...
Omacetaxine mepesuccinate is used for chronic myeloid leukemia and other hematologic malignancies. It is a small molecule oncology drug developed by Teva Pharmaceutical Industries Limited. Clinical development has focused on patients with advanced CML, including those whose disease carries the T315I BCR-ABL gene mutation.
Omacetaxine mepesuccinate is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical program studying the drug in chronic myeloid leukemia and other hematologic malignancies.
Omacetaxine mepesuccinate has been studied in Phase 2 clinical development for chronic myeloid leukemia and hematologic malignancies. Two completed trials are recorded, one Phase 1 pharmacokinetic study and one Phase 2 study, with no active trials currently listed. It is an investigational agent in the studies described here.
Omacetaxine mepesuccinate has been evaluated in completed trials including NCT00462943, an open-label Phase 2 study in advanced CML, and NCT00375219, a Phase 2 study in CML patients with the T315I BCR-ABL gene mutation. A Phase 1 pharmacokinetic study, NCT01844869, enrolled six patients with hematologic malignancies or solid tumors.
Yes. Omacetaxine mepesuccinate is also known as homoharringtonine, and the two names refer to the same small molecule. Trial records use both names, including NCT00375219 and NCT00462943, which describe homoharringtonine (omacetaxine mepesuccinate) in chronic myeloid leukemia.
Across the recorded clinical trials, 203 patients have been enrolled in studies of omacetaxine mepesuccinate. The largest was a Phase 2 CML study with 103 patients, followed by another Phase 2 CML study with 100 patients. A Phase 1 pharmacokinetic study enrolled six patients.