← Back to all trials
Active Not Recruiting
NCT00777582
Phase I Comparative Bioavailability Study
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 197
Sponsor: AstraZeneca
Location: Research Site Randwick
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
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).
Source: ClinicalTrials.gov (NCT00777582). StuddyBuddy aggregates publicly available trial information.