An Open-Label, Dose-Escalation Study of AZD2461

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Cancer Tumor

Refractory Solid Tumors

Treatments

Drug: AZD2461

Study type

Interventional

Funder types

Industry

Identifiers

NCT01247168

D3660C00001

Details and patient eligibility

About

This study is being conducted to test study drug AZD2461 to see how it may work to treat solid tumors. The main purpose of this study is to determine the safety and tolerability of AZD2461. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD2461 in the body over a period of time and will indicate whether the drug has a therapeutic effect on solid tumors.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
Patients must be 18 years of age
Using adequate contraceptive measures, be surgically sterile or post-menopausal
Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study..

Exclusion criteria

Patients currently receiving cancer therapy
Use of investigation anti-cancer drug or major surgery, radiotherapy or immunotherapy with the last 21 days
cardiac disease