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Trebananib · 2 trials · 17 indications
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: an AE that: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an other significant medical hazard. Treatment-emergent AEs (TEAEs) are those that occurred after the first administration of study drug through 30 days after the last study drug administration. Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).
A trebananib dose was considered delayed if it was administered 11 or more days from the previous trebananib infusion. A sunitinib dose was considered delayed if it was administered 3 or more days from the previous dose, except during holidays.
Participants who had a sunitinib dose modification within 12 weeks from their first dose due to adverse event, laboratory toxicity, or laboratory toxicity and adverse event.
Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).
Adverse events will be tabulated overall and by arm.
A population PK/PD model will be developed to characterize the time course of AMG 386 concentrations in relation to target inhibition and hematological response. Model-predicted PK parameters will be generated, such as individual areas-under-the-curve (AUCs) and Cmax for AMG 386, to correlate with targeted biomarkers, such as Ang1, and Ang2, and VEGF as well as leukocyte count.
A population PK/PD model will be developed to characterize the time course of AMG 386 concentrations in relation to target inhibition and hematological response. Model-predicted PK parameters will be generated, such as individual AUCs and Cmax for AMG 386, to correlate with targeted biomarkers, such as Ang1, and Ang2, and VEGF as well as leukocyte count.
| Arm | Type | Description |
|---|---|---|
| Trebananib 10 mg/kg + Sunitinib | EXPERIMENTAL | Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off |
| Trebananib 15 mg/kg + Sunitinib | EXPERIMENTAL | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| Arm A (trebananib) | EXPERIMENTAL | Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. |
| Arm B (trebananib, cytarabine) | EXPERIMENTAL | Patients receive trebananib as in Arm A. Patients also receive cytarabine SC BID on days 1-14 of course 1 and days 1-7 of subsequent courses. |
| Name | Type | Description |
|---|---|---|
| Sunitinib | DRUG | Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants. |
| Trebananib | DRUG | Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death. |
| cytarabine | DRUG | Given SC |
| laboratory biomarker analysis | OTHER | Correlative studies |
| pharmacological study | OTHER | Correlative studies |
Inclusion Criteria: * Subjects must have a histologically confirmed metastatic renal cell cancer (RCC) with a clear cell component * Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification * Measurable disease with at least one unidime...
Trebananib is an investigational oncology drug being studied for adult acute megakaryoblastic leukemia (M7) and advanced renal cell carcinoma. It is a small molecule developed by Amgen Inc. (AMGN). Trebananib is not FDA approved and remains in clinical development.
Trebananib is an investigational small molecule being studied in oncology. Its molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for adult acute megakaryoblastic leukemia (M7) and advanced renal cell carcinoma.
Trebananib is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials of Trebananib in oncology indications including advanced renal cell carcinoma and acute myeloid leukemia.
Trebananib is in Phase 2 clinical development for advanced renal cell carcinoma, based on a completed Phase 2 trial. It is also being studied in a Phase 1 trial for acute myeloid leukemia. Trebananib is investigational and not FDA approved.
Trebananib has two completed clinical trials. NCT00853372 was a Phase 2 open-label study in advanced renal cell carcinoma with 85 participants. NCT01555268 was a Phase 1 study of Trebananib with or without low-dose cytarabine in acute myeloid leukemia with 24 participants.
Trebananib is the same drug as AMG 386. The Phase 2 trial NCT00853372 is titled 'AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib,' confirming that AMG 386 is an alternative name for Trebananib.