A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

Novartis

Status and phase: Terminated; Phase 1

Conditions: Metastatic Cancer

Treatments: Drug: ASA404, DMXAA or DXAA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278758

EudraCT 2009-017159-88 (Registry Identifier)

CASA404A2109

Details and patient eligibility

About

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.

Enrollment: 7 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 1 patient group

ASA404 + standard therpy

Experimental group

Treatment:

Drug: ASA404, DMXAA or DXAA