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D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

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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

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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