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Phase I Comparative Bioavailability Study

Active Not RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Solid Tumors

Interventions: AZD2281

Countries: Australia, Belgium, Switzerland, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (10)

Randwick, Australia
Leuven, Belgium
Bellinzona, Switzerland
Edinburgh, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle upon Tyne, United Kingdom
Northwood, United Kingdom
Oxford, United Kingdom
Sutton, United Kingdom