NCT02544438

Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

a Phase i/Iia, Open Label, Uncontrolled Study to Evaluate the Safety and Efficacy of Astarabine (BST-236) as Single Agent in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: BioSight Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease

Detailed description

This is prospective, Phase I/IIa, open-label, uncontrolled, single-center, single arm study to evaluate the safety and efficacy of Astarabine given intravenously (I.V.) in escalated doses for 6 days for cycle in patients with relapsed or refractory AML or ALL who are more than 18 years of age. Patients will be screened for eligibility based on existing records and/or specific laboratory examinations performed for the screening process. Patients will be gradually enrolled into 4 subsequent cohorts of escalating drug doses: Cohort # Astarabine Dose Number of Patients 1. 0.5 gr/m2 (0.3 age\>50) 3 2. 1.5 gr/m2 (0.8age\>50) 3 3. 3.0 gr/m2 (1.5 age\>50) 3 4. 4.5 gr/m2 (2.3 age\>50) 6 5. 4.5 gr/m2 (no age limit) 3 up to 6 6. 6 gr/m2 (no age limit) 3 up to 6 Maximal tolerated dose (MTD) will be defined in case 2 subjects will experience a dose limiting toxicity (DLT)

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Astarabine (BST-236)	Cohort # Astarabine Dose Number of Patients 1. 0.5 gr/m2 (0.3 age\>50) 3 2. 1.5 gr/m2(0.8age\>50) 3 3. 3.0 gr/m2(1.5 age\>50) 3 4. 4.5 gr/m2(2.3 age\>50) 6 5. 4.5 gr/m2 (no age limit) 3 up to 6 6. 6 gr/m2 (no age limit) 3 up to 6 Total number of patients: up to 24

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2015-09-09
• Last updated: 2017-09-27

Locations

2 sites across 1 country: Israel