Overview

This trial is active, not recruiting.

Condition solid tumours
Treatments olaparib, dietary fasted, dietary standard, dietary high fat
Phase phase 1
Target PARP
Sponsor AstraZeneca
Start date July 2013
End date October 2013
Trial size 35 participants
Trial identifier NCT01851265, 2013-001255-13, D081AC00001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Arm
(Other)
Olaparib capsules following no breakfast
olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
dietary fasted
Allocated breakfast prior to dosing with 400mg olaparib capsules
(Other)
Olaparib capsules after standard breakfast
olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
dietary standard
Allocated breakfast prior to dosing with 400mg olaparib capsules
(Other)
Olaparib capsules after high fat breakfast
olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
dietary high fat
Allocated breakfast prior to dosing with 400mg olaparib capsules

Primary Outcomes

Measure
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
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.
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
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.

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

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.
Principal investigator Christian Rolfo
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.