Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 1b/2, Open-Label, Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and PK and PD Profiles of Voreloxin Injection in Combination With Cytarabine in Patients With Relapsed or Refractory AML
Verified date | December 2017 |
Source | Sunesis Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.
Status | Completed |
Enrollment | 110 |
Est. completion date | February 15, 2012 |
Est. primary completion date | February 15, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
KEY INCLUSION CRITERIA 1. Relapsed or refractory AML subtypes defined by WHO, except acute promyelocytic leukemia. Relapsed/refractory disease may be de novo AML or secondary AML 2. Treated with one to threee induction/reinduction AML regimens, prior induction or consolidation therapy with cytarabine allowed 3. At least 10% blasts by BM biopsy or aspirate 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 5. Clinical laboratory values of a) Serum creatinine =1.5 mg/dL and calculated or measured creatinine clearance (CRcl) of =50 mL/min, b) Total bilirubin =1.5 X upper limit of normal and c) Aspartate aminotransferase (AST) or alkaline phosphatase =2.5 X ULN. KEY EXCLUSION CRITERIA Patients with: 1. Allogenic bone marrow transplant/stem cell transplant 2. Persistent, clinically significant, chronic toxicities from prior AML therapy that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with study procedures 3. Acute promyelocytic leukemia 4. Disseminated intravascular coagulation 5. Active infections, unless adequately treated with antibiotic, antiviral, or antifungal agents within in 7 days before Induction Day 1 6. Active central nervous system involvement by AML 7. Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia 8. A requirement for hemodialysis or peritoneal dialysis 9. A history of myocardial infarction within the 3 months before treatment with vosaroxin 10. A history of cerebrovascular accident/transient ischemic attack within the 3 months before treatment with vosaroxin 11. A thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days before treatment with vosaroxin 12. Investigational products taken within 28 days before treatment with vosaroxin, and non-investigational cancer therapies or radiation therapy within 14 days before treatment with vosaroxin, with the exception of hydroxyurea. 13. A known intolerance to cytarabine or known allergy to D-sorbitol or methanesulfonic acid (excipients used in vosaroxin) 14. Prior exposure to vosaroxin 15. Any other medical, psychological, or social condition that contraindicates their participation in the clinical study due to safety concerns or compliance with study procedures in the opinion of the Investigator,or Sunesis Medical Monitor In addition: 16. Women who are pregnant or breastfeeding 17. Women who are of childbearing potential or male patients who had partners of childbearing potential who were unwilling to use an approved, effective means of contraception according to the study site's standards |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University - Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Northwestern Medical Faculty Foundation | Chicago | Illinois |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | HealthOne Presbyterian/St. Luke's Medical Center | Denver | Colorado |
United States | Rocky Mountain Cancer Centers | Denver | Colorado |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | New York Presbyterian Hospital-Weill Cornell Medical College | New York | New York |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Sunesis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2) | Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose. | From start of treatment (Day 1) through Induction Day 29 or the start of reinduction, whichever occurred first. | |
Secondary | Remission Rates (CR+CRp) | Complete remission (CR) plus CR with incomplete platelet recovery (CRp) per The IWG criteria for remission modified by Sunesis, assessed by investigator. CR is defined as >1000 Neutrophils (ul), >100,000 Platelets (uL) and <5 BM Blasts (%); CRp is defined as >1000 Neutrophils (ul), <=100,000 Platelets (uL) and <5 BM Blasts (%); CRi is defined as >1000 Neutrophils (ul), <100,000 Platelets (uL) and <5 BM Blasts (%); Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (CR with morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse. |
Monthly after the end of treatment for the first year, then every 2 months thereafter for upto 2 years | |
Secondary | Leukemia-free Survival (LFS) | Leukemia-free survival is censored at the last known alive date without report of relapse. | From time of the start of CR or CRp to the earliest date of relapse, commencement of reinduction therapy, or death, assessed monthly up to 2 years after the end of study visit. | |
Secondary | Overall Survival | Overall survival is censored at the earlier of the cutoff date for analysis and the last date known to be alive for patients not known to have died. | Time between the date of first study treatment and the date of death due to any cause for upto 2 years after the end of study visit | |
Secondary | All Cause Mortality | Mortality of those patients enrolled in the study and receiving intervention | 30 and 60 days |
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