Clinical trial NCT01851265: D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumours
Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of Olaparib (Cmax and tmax)
timeFrame: 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
measure: Pharmacokinetics of Olaparib (AUC0-t)
timeFrame: 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.
measure: Pharmacokinetics of Olaparib (AUC)
timeFrame: 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
measure: Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½)
timeFrame: 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:
measure: Safety monitoring of Olaparib
timeFrame: 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
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Senior Research Physician
name: Anitra Fielding
role: STUDY_DIRECTOR
affiliation: UZ Antwerpen
name: Christian Rolfo
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Study Statistician
name: Wendy Bannister
role: STUDY_CHAIR
References: