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

Novartis

Status and phase

Terminated

Phase 1

Conditions

Metastatic Cancer With Normal Renal Function

Metastatic Cancer With Impaired Renal Function

Treatments

Drug: ASA404

Study type

Interventional

Funder types

Industry

Identifiers

NCT01240642

EudraCT 2009-011142-26 (Registry Identifier)

CASA404A2112

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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