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OpenTrials
Completed

NCT Number: NCT01247168

An Open-Label, Dose-Escalation Study of AZD2461

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.

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Key information

Conditions

Refractory Solid Tumors Cancer Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nashville, Tennessee, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2461

Drug

oral capsules, continuous dosing and intermittent dosing

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2010
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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