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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00777582




Registration number
NCT00777582
Ethics application status
Date submitted
21/10/2008
Date registered
22/10/2008

Titles & IDs
Public title
Phase I Comparative Bioavailability Study
Scientific title
A Phase I, Randomised, 2 Period Cross Over Study to Determine the Comparative Bioavailability of Two Different Oral Formulations of AZD2281 in Cancer Patients With Advanced Solid Tumours
Secondary ID [1] 0 0
2008-003697-18
Secondary ID [2] 0 0
D0810C00024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2281

Experimental: Treatment A - 300mg bid (twice daily) tablet dose

Experimental: Treatment B - 400 mg twice daily (bid) capsule dose

Experimental: Treatment C - 400mg bid (twice daily) tablet dose


Treatment: Drugs: AZD2281
Oral single dose formulation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation
Timepoint [1] 0 0
Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose
Primary outcome [2] 0 0
Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients
Timepoint [2] 0 0
every 28 days
Primary outcome [3] 0 0
Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs
Timepoint [3] 0 0
at every visit
Primary outcome [4] 0 0
Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule
Timepoint [4] 0 0
at every visit
Primary outcome [5] 0 0
Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation.
Timepoint [5] 0 0
at every visit
Secondary outcome [1] 0 0
PK Phase Secondary Outcome: To generate single dose PK data for the new tablet formulation in man, and to generate information on dose linearity for the new tablet formulation
Timepoint [1] 0 0
Blood samples (12) will be taken at pre-defined intervals prior to and following dosing of a single capsule and a single tablet dose
Secondary outcome [2] 0 0
To compare the extent of PARP inhibition achieved in peripheral blood mononuclear cells (PBMCs) following dosing of both the new tablet formulation and existing capsule formulation
Timepoint [2] 0 0
Blood samples (4) will be taken at pre-defined intervals prior to and following dosing of a single capsule and a single tablet dose
Secondary outcome [3] 0 0
To determine the safety and tolerability of AZD2281 for both the new tablet formulation and existing capsule formulations
Timepoint [3] 0 0
every 28 days
Secondary outcome [4] 0 0
Continued Supply Expansion Phase: To compare the steady state exposure achieved with 200mg bid tablet formulation and 400mg bid capsule formulation
Timepoint [4] 0 0
at visit 3 and visit 4
Secondary outcome [5] 0 0
Continued Supply Expansion Phase: To describe the efficacy data observed in patients treated with the capsule and the tablet
Timepoint [5] 0 0
RECIST, Progression Free Survival, Best overall response and CA-125 response
Secondary outcome [6] 0 0
Dose Escalation Phase of the continued supply expansion: To determine the single dose and steady state exposures achieved with higher doses of AZD2281 tablet formulation
Timepoint [6] 0 0
at every visit
Secondary outcome [7] 0 0
Dose Escalation Phase of the continued supply expansion: To compare between patients the single dose and steady state exposures of AZD2281 achieved with selected tablet doses and the 400mg bid capsule dose
Timepoint [7] 0 0
at every visit
Secondary outcome [8] 0 0
Dose Escalation Phase of the continued supply expansion: To describe the efficacy data observed in patients treated with the capsule formulation and the tablet formulation
Timepoint [8] 0 0
at every visit
Secondary outcome [9] 0 0
Randomised tablet formulation continued supply expansion phase (Group 8): To determine the single dose and steady state exposures achieved with the selected table dose schedules of AZD2281 melt-extrusion (tablet) formulation
Timepoint [9] 0 0
at every visit
Secondary outcome [10] 0 0
Randomised tablet formulation continued supply expansion phase (Group 8): To obtain a preliminary assessment of the effect of food on the exposure to AZD2281 following dosing of the melt-extrusion (tablet) formulation.
Timepoint [10] 0 0
at every visit
Secondary outcome [11] 0 0
Randomised tablet formulation continued supply expansion phase (Group 8): To describe the efficacy data observed in patients treated with the melt-extrusion (tablet) formulation
Timepoint [11] 0 0
at every visit

Eligibility
Key inclusion criteria
* Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists
* Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment
* Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids
* Patients with symptomatic uncontrolled brain metastases
* Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery
* Patients who are platinum refractory (Group 8 only)
* Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
197
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Switzerland
State/province [2] 0 0
Bellinzona
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Edinburgh
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Manchester
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Newcastle upon Tyne
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Northwood
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Oxford
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson, BSc, MBCHB, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00777582