A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function
- Conditions
- Metastatic Cancer
- Interventions
- Drug: ASA404, DMXAA or DXAA
- Registration Number
- NCT01278758
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy;
- Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
- Creatinine clearance according to Cockcroft-Gault formula : Normal > 80 mL/min, Mild 50-80 mL/min, Moderate 30-<50 mL/min;
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies;
- Potassium, calcium, magnesium and phosphorus values within the normal range;
- Body Mass Index (BMI) must be within the range of 18 and 30
- Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases;
- Patients with leptomeningeal disease metastases;
- Radiotherapy </- weeks prior to starting study drug;
- Major surgery </ 4 weeks prior to the start of study;
- Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug;
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASA404 + standard therpy ASA404, DMXAA or DXAA -
- Primary Outcome Measures
Name Time Method To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function 12 months
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function 12 months To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function 12 months To evaluate renal clearance (CLR) of ASA404.
Trial Locations
- Locations (4)
Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
🇺🇸Indianapolis, Indiana, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Hematology /Oncology Associates
🇺🇸Rockville, Maryland, United States