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Active (not recruiting) Phase 1 NCT00777582

Phase I Comparative Bioavailability Study

Phase 1 – testing safety in a small group of people
Conditions: Solid Tumors

Sponsor: AstraZeneca

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Overview
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
Who can participate
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).
Locations 4
Australia (1)
Research Site
Randwick
Belgium (1)
Research Site
Leuven
Switzerland (1)
Research Site
Bellinzona
United Kingdom (1)
Research Site
Edinburgh
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
27.10.2008
Completion date
31.03.2026
Registry ID
NCT00777582
Source
anzctr
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