Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid Tumors

NCT01245543 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-11-02

No results posted yet for this study

Summary

AC480IV will be administered as a monotherapy and then in combination with docetaxel in patients with locally advanced or metastatic solid tumors for whom there are no standard or curative therapies available. It is designed to evaluate the safety and pharmacokinetic parameters of AC480IV as monotherapy and also in combination with docetaxel under the conditions of the study.

Conditions

Interventions

DRUG

AC480IV

AC480IV will be administered as an infusion using a dose escalation design.

DRUG

Docetaxel

Docetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration.

Sponsors & Collaborators

Principal Investigators

  • Guy Gammon, MB BS, MRCP · Interim Chief Medical Officer / Ambit Biosciences Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245543 on ClinicalTrials.gov