D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-04

Study Completion Date

2017-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fasted

Olaparib capsules following no breakfast

Group Type OTHER

Olaparib

Intervention Type DRUG

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Dietary Fasted

Intervention Type OTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

Standard meal

Olaparib capsules after standard breakfast

Group Type OTHER

Olaparib

Intervention Type DRUG

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Dietary standard

Intervention Type OTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

High Fat

Olaparib capsules after high fat breakfast

Group Type OTHER

Olaparib

Intervention Type DRUG

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Dietary High Fat

Intervention Type OTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

Interventions

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Olaparib

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Intervention Type DRUG

Dietary Fasted

Allocated breakfast prior to dosing with 400mg olaparib capsules

Intervention Type OTHER

Dietary standard

Allocated breakfast prior to dosing with 400mg olaparib capsules

Intervention Type OTHER

Dietary High Fat

Allocated breakfast prior to dosing with 400mg olaparib capsules

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No