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An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function

NCT ID: NCT01278849

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. The study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. The assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. The Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.

Detailed Description

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Conditions

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Histologically-proven and Radiologically-confirmed Solid Tumors

Keywords

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

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

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 refractory to standard chemotherapy;
* Patients whom chemotherapy with an investigational agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
* Age ≥ 18 years old
* Creatinine clearance according to Cockcroft-Gault formula ≥ 60 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 Total bilirubin ≤ 6 X ULN

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;
* Major surgery \</ 4 weeks prior to the start of study;
* Prior exposure to VDAs or other vascular targeting agents;
* Right bundle branch block (RBBB), complete left bundle branch block (LBBB);
* 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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Novartis Investigative Site

Ancona, AN, Italy

Site Status

Novartis Investigative Site

Milan, , Italy

Site Status

Novarts Investigative Site

Auckland, , New Zealand

Site Status

Novartis Investigative Site

Wellington, , New Zealand

Site Status

Countries

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Italy New Zealand

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5164

Results for CASA404A2105 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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EudraCT 2009-016471-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASA404A2105

Identifier Type: -

Identifier Source: org_study_id