Status:
COMPLETED
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Solid Tumours
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
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 differ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01851265
Start Date
July 4 2013
End Date
June 6 2017
Last Update
August 28 2017
Active Locations (7)
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1
Research Site
Edegem, Belgium, 2650
2
Research Site
Leuven, Belgium, 3000
3
Research Site
Wilrijk, Belgium, 2610
4
Research Site
Amsterdam, Netherlands, 1081 HV