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Sponsors and Collaborators: |
AstraZeneca KuDOS Pharmaceuticals Limited |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00633269 |
Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.
Condition | Intervention | Phase |
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Neoplasm Metastasis |
Drug: AZD2281 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Open, Non-Randomized, Single Centre Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of a Single Oral 100 mg Dose of [14C]-AZD2281 (KU-0059436) in Patients With Advanced or Metastatic Solid Tumours Refractory to Standard Treatments |
Estimated Enrollment: | 6 |
Study Start Date: | April 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Research Site | |
London, United Kingdom |
Study Director: | James Carmichael, BSc, MBChB, MD, FRCP | KuDOS Pharmaceuticals, Ltd |
Principal Investigator: | Johann deBono, MD, FRCP, MSc PhD | Royal Marsden Hospital, Surrey, UK |
Responsible Party: | AstraZeneca ( Jim Carmichael - CMO ) |
Study ID Numbers: | D0810C00010, KU36-37 |
Study First Received: | March 5, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00633269 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Poly(ADP ribose) polymerases Metastatic Solid Tumours |
Neoplasm Metastasis |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |