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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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00777582). StuddyBuddy aggregates publicly available trial information.