Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT01555268
Brief Summary:
This phase I trial studies the side effects and the best dose of trebananib when given together with or without low-dose cytarabine in treating patients with acute myeloid leukemia (AML). Trebananib may stop the growth of AML by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving trebananib together with cytarabine may be an effective treatment for patients with AML.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profile of AMG 386 (trebananib) when administered alone and in combination with low-dose cytarabine in adult patients with: untreated AML considered ineligible for standard induction chemotherapy; refractory and/or relapsed AML following at least one cycle of prior therapy who are not currently eligible for stem cell transplantation.
SECONDARY OBJECTIVES:
I. To evaluate clinical responses in AML patients following AMG 386 therapy alone or in combination with low-dose cytarabine therapy.
II. To characterize the biological changes occurring in AML patients treated with AMG 386 alone or in combination with low-dose cytarabine, specifically: alteration in angiopoietin (Ang)1, Ang2, Tie2, vascular endothelial growth factor (VEGF), and VEGF receptor (VEGFR) expression; changes in bone marrow vascularization and hypoxia; changes in gene and/or micro ribonucleic acid (microRNA) expression; PK/PD modeling to characterize the time course of AMG 386 concentrations in relation to target inhibition and hematological response.
III. To determine whether the above biological changes correlate with and/or predict for clinical response in AML patients treated on this study.
OUTLINE: This is a dose-escalation study of trebananib. Patients are assigned to 1 of 2 treatment arms.
ARM A: Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22.
ARM B: Patients receive trebananib as in Arm A. Patients also receive cytarabine subcutaneously (SC) twice daily (BID) on days 1-14 of course 1 and days 1-7 of each subsequent course.
In both arms, treatment repeats every 28 days\* for up to 12 courses in the absence of disease progression or unacceptable toxicity.
NOTE: \*Course 1 is 35 days.
After completion of study treatment, patients are followed up for 30 days, every month for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.
Study:
NCT01555268
Study Brief:
Protocol Section:
NCT01555268