D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

• Status: Completed
• Trial end date: 2017-06-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• Patients aged ≥18 years, male and female

• Able to eat a high-fat breakfast within a 30-minute period, as provided by the study site

• Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists

• ECOG performance status ≤2

• Normal organ and bone marrow function measured within 28 days prior to administration of IP as defined in protocol

Exclusion Criteria:

• Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used)

• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 2 weeks prior to study treatment (or a longer period depending on the defined characteristics of the agents used).

• Toxicities (≥CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia

• Patients unable to fast for up to 14 hours or who have type I or type II diabetes

• Patients who have gastric, gastro-oesophageal or oesophageal cancer