Skip to main content
OpenTrials
Completed

NCT Number: NCT01851265

D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumours Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olaparib

Drug

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

Dietary Fasted

Other

Allocated breakfast prior to dosing with 400mg olaparib capsules

Dietary standard

Other

Allocated breakfast prior to dosing with 400mg olaparib capsules

Dietary High Fat

Other

Allocated breakfast prior to dosing with 400mg olaparib capsules

Primary outcomes

  1. Pharmacokinetics of Olaparib (Cmax and tmax)

    Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose

    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax)

  2. Pharmacokinetics of Olaparib (AUC0-t)

    Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.

    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)

  3. Pharmacokinetics of Olaparib (AUC)

    Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose

    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)

  4. Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½)

    Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.

    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)

Secondary outcomes

  1. Safety monitoring of Olaparib

    Time frame: AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue

    Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients With Advanced Solid Tumours.

Important dates

Study start
2013
Primary completion
2013
Study completion
2017
First posted
May 10, 2013
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.