Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 Major surgery 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 is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT01278758

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 4 Locations for this study

See Locations Near You

Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
Indianapolis Indiana, 46202, United States
Hematology /Oncology Associates
Rockville Maryland, 20850, United States
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
Detroit Michigan, 48202, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT01278758

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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