Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00633269
• Collaborator: KuDOS Pharmaceuticals Limited (Industry)
• Enrollment: 6
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis	Drug: AZD2281	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Outcome Measures

Primary Outcome Measures

1. 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 [Various timepoints]

Secondary Outcome Measures

1. To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs. []

2. To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites []

3. To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	London		United Kingdom

Sponsors and Collaborators

• AstraZeneca
• KuDOS Pharmaceuticals Limited

Investigators

• Study Director: James Carmichael, BSc, MBChB, MD, FRCP, KuDOS Pharmaceuticals, Ltd
• Principal Investigator: Johann deBono, MD, FRCP, MSc PhD, Royal Marsden Hospital, Surrey, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00633269
• Other Study ID Numbers: D0810C00010; KU36-37
• First Posted: Mar 12, 2008
• Last Update Posted: Jan 14, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Poly(ADP ribose) polymerases; Metastatic Solid Tumours
• Additional relevant MeSH terms: Neoplasm Metastasis; Olaparib

Study Results

No Results Posted as of Jan 14, 2009