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NCT00777582 Clinical Trial

Phase I Comparative Bioavailability Study

Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00777582
Other study ID # D0810C00024
Secondary ID 2008-003697-18
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 27, 2008
Est. completion date March 31, 2025

Study information
Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this phase I randomised cross over study is to determine and compare the bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer patients

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 197
Est. completion date March 31, 2025
Est. primary completion date February 6, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2281
Oral single dose formulation

Locations
Country Name City State
Australia Research Site Randwick
Belgium Research Site Leuven
Switzerland Research Site Bellinzona
United Kingdom Research Site Edinburgh
United Kingdom Research Site Manchester
United Kingdom Research Site Newcastle upon Tyne
United Kingdom Research Site Oxford
United Kingdom Research Site Sutton

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Belgium,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose
Primary 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 every 28 days
Primary 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 at every visit
Primary 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 at every visit
Primary 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. at every visit
Secondary 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 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 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 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 To determine the safety and tolerability of AZD2281 for both the new tablet formulation and existing capsule formulations every 28 days
Secondary Continued Supply Expansion Phase: To compare the steady state exposure achieved with 200mg bid tablet formulation and 400mg bid capsule formulation at visit 3 and visit 4
Secondary Continued Supply Expansion Phase: To describe the efficacy data observed in patients treated with the capsule and the tablet RECIST, Progression Free Survival, Best overall response and CA-125 response
Secondary 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 at every visit
Secondary 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 at every visit
Secondary 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 at every visit
Secondary 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 at every visit
Secondary 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. at every visit
Secondary Randomised tablet formulation continued supply expansion phase (Group 8): To describe the efficacy data observed in patients treated with the melt-extrusion (tablet) formulation at every visit
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