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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis

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Trial Information

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


Inclusion Criteria:



- Histologically confirmed advanced or metastatic tumour, refractory to standard
therapies

Exclusion Criteria:

- Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative
radiotherapy), endocrine therapy, immunotherapy or use of other investigational
agents within 4 weeks prior to study entry.

- Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone
disease and corticosteroids provided the dose is stable before and during the study.

- Females will be able to continue to take hormone replacement therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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, assessed by blood, urine and faecal sampling

Outcome Time Frame:

Various timepoints

Safety Issue:

No

Principal Investigator

James Carmichael, BSc, MBChB, MD, FRCP

Investigator Role:

Study Director

Investigator Affiliation:

KuDOS Pharmaceuticals, Ltd

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D0810C00010

NCT ID:

NCT00633269

Start Date:

April 2008

Completion Date:

October 2008

Related Keywords:

  • Neoplasm Metastasis
  • Poly(ADP ribose) polymerases
  • Metastatic Solid Tumours
  • Neoplasms
  • Neoplasm Metastasis

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