Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Marqibo · 2 trials · 2 indications
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.
Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC\>=1X10\^9/L or Platelet count\>=100x10\^9/L, absence of blasts in blood and morrow (\<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count \<100x10\^9/L or ANC\<1x10\^9/L.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. |
| Cohort 2 | EXPERIMENTAL | Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. |
| Marqibo | EXPERIMENTAL | Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes). |
| Name | Type | Description |
|---|---|---|
| Marqibo® (vincristine sulfate liposomes injection) | DRUG | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. |
Inclusion Criteria: * Uveal melanoma with histologic or cytologic confirmation of metastatic disease. * One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be \>20 mm with con...
Marqibo is an investigational small molecule being studied for the treatment of metastatic malignant uveal melanoma and acute lymphoblastic leukemia (ALL). It is in Phase 2 clinical development for these oncology indications.
Marqibo is being developed by Assertio Holdings, Inc., a company traded on the stock exchange under the ticker symbol ASRT.
Marqibo is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any use.
Marqibo has been studied in two completed Phase 2 trials: NCT00495079 in relapsed acute lymphoblastic leukemia and NCT00506142 in metastatic malignant uveal melanoma. Both trials were uncontrolled and enrolled adult patients.
Marqibo is a formulation of vincristine, a chemotherapy agent. It is being studied as a targeted therapy in biomarker-selected patient populations for the treatment of certain cancers.