NCT01851265

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_1

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2013

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

May 8, 2013

Last Update Submit

August 25, 2017

Conditions

Solid Tumours

Keywords

oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics of Olaparib (Cmax and tmax)

    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)

    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

  • Pharmacokinetics of Olaparib (AUC0-t)

    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)

    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.

  • Pharmacokinetics of Olaparib (AUC)

    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)

    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

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

    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)

    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.

Secondary Outcomes (1)

  • Safety monitoring of Olaparib

    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

Study Arms (3)

Fasted

OTHER

Olaparib capsules following no breakfast

Drug: OlaparibOther: Dietary Fasted

Standard meal

OTHER

Olaparib capsules after standard breakfast

Drug: OlaparibOther: Dietary standard

High Fat

OTHER

Olaparib capsules after high fat breakfast

Drug: OlaparibOther: Dietary High Fat

Interventions

OlaparibDRUG

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

FastedHigh FatStandard meal
Dietary FastedOTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

Fasted
Dietary standardOTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

Standard meal
Dietary High FatOTHER

Allocated breakfast prior to dosing with 400mg olaparib capsules

High Fat

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Edegem, 2650, Belgium

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Wilrijk, 2610, Belgium

Location

Research Site

Amsterdam, 1081 HV, Netherlands

Location

Research Site

Maastricht, 6202 AZ, Netherlands

Location

Research Site

Glasgow, G12 0YN, United Kingdom

Location

Research Site

Manchester, M20 4BX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

olaparib

Study Officials

  • Anitra Fielding

    AstraZeneca Senior Research Physician

    STUDY DIRECTOR

  • Christian Rolfo

    UZ Antwerpen

    PRINCIPAL INVESTIGATOR

  • Wendy Bannister

    AstraZeneca Study Statistician

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 10, 2013

Study Start

July 4, 2013

Primary Completion

October 18, 2013

Study Completion

June 6, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

GB(2)BE(3)NL(2)