NCT01247168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

November 8, 2010

Last Update Submit

June 5, 2012

Conditions

Refractory Solid TumorsCancer Tumor

Keywords

RefractorySolid tumorsCancer

Outcome Measures

Primary Outcomes (3)

  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs.

    Day 1

  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs.

    Day 8

  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs.

    every 3 weeks after day 8

Secondary Outcomes (4)

  • To characterize the pharmacokinetic profile of AZD2461 by collection of blood samples for the measurement of AZD2461 in plasma concentration

    Continuous dosing Cycle 1 and 2, Day 1 (pre-dose, 1-hr, 6-hr and 24-hr)

  • To characterize the pharmacokinetic profile of AZD2461 by collection of blood samples for the measurement of AZD2461 in plasma concentration

    Intermittent dosing Cycle 1, Day 1 and Day 14 (pre-dose, 1-hr, 6 hr and 24-hr) Day 18 (+/- 2 days) Cycle 2, Day 1 (pre-dose)

  • evaluate the pharmacodynamic response after treatment with AZD2461 as the change in PARP (Poly (ADP-ribose) polymerase) inhibition in PBMCs (peripheral blood mononuclear cell)

    weekly

  • To explore the clinical tumor response after treatment with AZD2461 as the assessment of patients with overall tumor response Complete Response (CR), Partial Response (PR), duration of response, stable disease (SD) and time to disease progression

    every 6 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD2461

Interventions

AZD2461DRUG

oral capsules, continuous dosing and intermittent dosing

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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..

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AZD2461

Study Officials

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

    AstraZeneca

    STUDY DIRECTOR

  • Dr. Jeffrey Infante, MD

    Sarah Cannon Research Institute (SCRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

US(1)