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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function

Intervention / Treatment
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* Drug: ASA404


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASA404<br> | Drug: ASA404<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 monnths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) |  | 12 months | 
| To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax |  | 12 months | 
| To evaluate renal clearance (CLR) of ASA404. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced or metastatic cancer, refractory, core phase, extension phase, dose escalation, standard chemotherapy, doctaxel, paclitaxel, carboplatin, safety, tolerability