An Open-Label, Dose-Escalation Study of AZD2461

NCT ID: NCT01247168

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

Brief Summary

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.

Conditions

Refractory Solid Tumors; Cancer Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

AZD2461

Intervention Type: DRUG

oral capsules, continuous dosing and intermittent dosing

Interventions

AZD2461

oral capsules, continuous dosing and intermittent dosing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Hughes, MA, MB, ChB, PhD, P

Role: STUDY_DIRECTOR

AstraZeneca

Dr. Jeffrey Infante, MD

Role: PRINCIPAL_INVESTIGATOR

Sarah Cannon Research Institute (SCRI)

Locations

Research Site

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

D3660C00001

Identifier Type: -

Identifier Source: org_study_id