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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01278758

Collaborator

(none)

Enrollment

Locations

Arm

1.8

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Drug: ASA404, DMXAA or DXAA	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASA404 + standard therpy	Drug: ASA404, DMXAA or DXAA

Arm

Intervention/Treatment

Experimental: ASA404 + standard therpy

Drug: ASA404, DMXAA or DXAA

Outcome Measures

Primary Outcome Measures

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 months]

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 [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) []
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax []
To evaluate renal clearance (CLR) of ASA404. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.	Indianapolis	Indiana	United States	46202
2	Hematology /Oncology Associates	Rockville	Maryland	United States	20850
3	Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System	Detroit	Michigan	United States	48202
4	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109-1023