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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

NCT ID: NCT01240642

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASA404

Group Type EXPERIMENTAL

ASA404

Intervention Type DRUG

Interventions

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ASA404

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 Pharmaceuticals

Locations

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Novartis Investigative Site

Charleroi, , Belgium

Site Status

Novartis Investigative Site

Jette, , Belgium

Site Status

Novartis Investigative Site

Saint-Lambert, , Belgium

Site Status

Novartis Investigative Site

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5424

Results for CASA404A2112 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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EudraCT 2009-011142-26

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASA404A2112

Identifier Type: -

Identifier Source: org_study_id