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

NCT ID: NCT01278758

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Cancer

Keywords

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Advanced or metastatic cancer, refractory, core phase, extension phase, dose escalation, standard chemotherapy, doctaxel, paclitaxel, carboplatin, safety, tolerability

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASA404 + standard therpy

Group Type EXPERIMENTAL

ASA404, DMXAA or DXAA

Intervention Type DRUG

Interventions

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ASA404, DMXAA or DXAA

Intervention Type DRUG

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Investigative Site

Locations

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Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.

Indianapolis, Indiana, United States

Site Status

Hematology /Oncology Associates

Rockville, Maryland, United States

Site Status

Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System

Detroit, Michigan, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5426

Results for CASA404A2109 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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EudraCT 2009-017159-88

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASA404A2109

Identifier Type: -

Identifier Source: org_study_id