advanced solid tumors (ie, breast, lung, head/neck,colorectal, melanoma, and sarcoma) Solid tumors
Conditions
Interventions
Assessment period 1 (Cycle 1 : days 1-8). On the first day of treatment: 14C
vosaroxin (single dose). Hospital admission 9 nights, for blood collection and
collection of urine and feces. Assessment
Sponsors
Sunesis Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and provide written informed consent; 2. At least 18 years old at the time of informed consent; 3. Histologically or cytologically confirmed diagnosis of advanced solid tumors (ie, breast, lung, head/neck, colorectal, melanoma, and sarcoma). The malignancy must be considered unresponsive to accepted available therapies; 4. ECOG performance status of 0, 1, or 2; 5. Life expectancy of >= 3 months; 6. Acceptable recovery from clinically significant nonhematologic toxicity after prior therapy; 7. If female, must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before randomization, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method; of contraception during the study until 30 days after the last treatment; 8. Adequate renal function (normal to mild dysfunction), with a serum creatinine value of >1.5 x the upper limit of normal (ULN) and with a calculated creatinine clearance (CLCR) of >=40 mL/minute; 9. Adequate hepatic function defined as follows; - total bilirubin
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days of the first dose of study treatment or has not recovered from adverse events (AEs) due to any agents administered previously; 2. Presence of known brain metastases or active central nervous system (CNS) disease; 3. Prior treatment with vosaroxin within 60 days of enrollment; 4. Prior treatment with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed); 5. New York Heart Association Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure; 6. Myocardial infarction within the previous 12 weeks; 7. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8. Pregnant or lactating; 9. Known positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HC Ab) or has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.;10. Presence of inflammatory bowel disease, occlusion of the gastrointestinal tract, significant constipation, or any condition resulting in clinically significant obstruction of the gastrointestinal tract.;11. History of biliary obstruction or cholecystectomy.;12. Any condition resulting in a clinically significant obstruction of the urinary tract.;13. Known hypersensitivity to vosaroxin or any other components of the study treatment.;14. Serious medical or psychiatric condition that, in the opinion of the Investigator, should preclude the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Since this is a Phase 1 PK study, there are no primary or secondary endpoint right now. The primary objective for this study is: To quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of 14C-vosaroxin and its metabolites in patients with advanced solid tumors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Since this is a Phase 1 PK study, there are no primary or secondary endpoint right now. Secondary objective for this study is: To evaluate safety and tolerability of vosaroxin in patients with advanced solid tumors. | — |
Countries
Netherlands
Outcome results
None listed