NCT00633269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

March 5, 2008

Last Update Submit

January 13, 2009

Conditions

Neoplasm Metastasis

Keywords

Poly(ADP ribose) polymerasesMetastatic Solid Tumours

Outcome Measures

Primary Outcomes (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 Outcomes (3)

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

  • To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites

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

Interventions

AZD2281DRUG

100mg Oral Dose

Also known as: Olaparib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

olaparib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James Carmichael, BSc, MBChB, MD, FRCP

    KuDOS Pharmaceuticals, Ltd

    STUDY DIRECTOR

  • Johann deBono, MD, FRCP, MSc PhD

    Royal Marsden Hospital, Surrey, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

GB(1)