An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404
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The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.
Condition or disease
Metastatic Cancer With Impaired Renal FunctionMetastatic Cancer With Normal Renal Function
A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404
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 [ Time Frame: 12 monnths ]
Secondary Outcome Measures :
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 [ Time Frame: 12 months ]
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function [ Time Frame: 12 months ]
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) [ Time Frame: 12 months ]
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax [ Time Frame: 12 months ]
To evaluate renal clearance (CLR) of ASA404. [ Time Frame: 12 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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