D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Other: Dietary standard; Other: Dietary High Fat; Drug: Olaparib; Other: Dietary Fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT01851265

D081AC00001

2013-001255-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Fasted

Other group

Description:

Olaparib capsules following no breakfast

Treatment:

Other: Dietary Fasted

Drug: Olaparib

Standard meal

Other group

Description:

Olaparib capsules after standard breakfast

Treatment:

Other: Dietary standard

Drug: Olaparib

High Fat

Other group

Description:

Olaparib capsules after high fat breakfast

Treatment:

Other: Dietary High Fat

Drug: Olaparib