Phase I Comparative Bioavailability Study

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Olaparib

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).