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NCT01278758 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
7
Enrollment target

NCT01278758 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 7 participants.

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The verdict

NCT01278758, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study 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.

Interventions

  • DRUG ASA404, DMXAA or DXAA

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-03
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01278758

The ClinicalTrials.gov registry entry for NCT01278758 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ASA404, DMXAA or DXAA is the first listed.

NCT01278758 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01278758 about?

NCT01278758 is a clinical study titled "A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function". 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 o...

What is the current status of trial NCT01278758?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2010-03.

What interventions are being tested in trial NCT01278758?

The interventions under investigation include: ASA404, DMXAA or DXAA (DRUG).

Who is sponsoring clinical trial NCT01278758?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.