search
Back to results

An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

Primary Purpose

Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function

Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
ASA404
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer With Impaired Renal Function 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

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASA404

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
November 11, 2010
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01240642
Brief Title
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404
Official Title
A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 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 determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASA404
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASA404
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 monnths
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)
Time Frame
12 months
Title
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
Time Frame
12 months
Title
To evaluate renal clearance (CLR) of ASA404.
Time Frame
12 months

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 Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Charleroi
Country
Belgium
Facility Name
Novartis Investigative Site
City
Jette
Country
Belgium
Facility Name
Novartis Investigative Site
City
Lambert
Country
Belgium
Facility Name
Novartis Investigative Site
City
Wilrijk
Country
Belgium

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5424
Description
Results for CASA404A2112 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

We'll reach out to this number within 24 hrs