An Open-Label, Dose-Escalation Study of AZD2461

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01247168
First received: November 8, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Refractory Solid Tumors
Cancer Tumor
Drug: AZD2461
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics fo the PARP Inhibitor AZD2461 in Patients With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs. [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs. [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs. [ Time Frame: every 3 weeks after day 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic profile of AZD2461 by collection of blood samples for the measurement of AZD2461 in plasma concentration [ Time Frame: Continuous dosing Cycle 1 and 2, Day 1 (pre-dose, 1-hr, 6-hr and 24-hr) ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetic profile of AZD2461 by collection of blood samples for the measurement of AZD2461 in plasma concentration [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
  • evaluate the pharmacodynamic response after treatment with AZD2461 as the change in PARP (Poly (ADP-ribose) polymerase) inhibition in PBMCs (peripheral blood mononuclear cell) [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD2461
oral capsules, continuous dosing and intermittent dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247168

Locations
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Andrew Hughes, MA, MB, ChB, PhD, P AstraZeneca
Principal Investigator: Dr. Jeffrey Infante, MD Sarah Cannon Research Institute (SCRI)
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01247168     History of Changes
Other Study ID Numbers: D3660C00001
Study First Received: November 8, 2010
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Refractory
Solid tumors
Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014