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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

Primary Purpose

Metastatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASA404, DMXAA or DXAA
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Advanced or metastatic cancer,, refractory,, core phase,, extension phase,, dose escalation,, standard chemotherapy,, doctaxel,, paclitaxel,, carboplatin,, safety,, tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
  • Hematology /Oncology Associates
  • Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASA404 + standard therpy

Arm Description

Outcomes

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

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
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
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.

Full Information

First Posted
January 16, 2011
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01278758
Brief Title
A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Advanced or metastatic cancer,, refractory,, core phase,, extension phase,, dose escalation,, standard chemotherapy,, doctaxel,, paclitaxel,, carboplatin,, safety,, tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASA404 + standard therpy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASA404, DMXAA or DXAA
Primary Outcome Measure Information:
Title
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Time Frame
12 months
Title
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time Frame
12 months
Title
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
Title
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
Title
To evaluate renal clearance (CLR) of ASA404.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 </- 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Investigative Site
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Hematology /Oncology Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5426
Description
Results for CASA404A2109 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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