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
18 Years
N/A
Both
Solid Tumours
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
Outcome Measure:
Pharmacokinetics of Olaparib (Cmax and tmax)
Outcome Description:
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)
Outcome 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
Safety Issue:
No
Principal Investigator
Kate K Owen
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca Senior Research Physician
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
D081AC00001
NCT ID:
NCT01851265
Start Date:
May 2013
Completion Date:
November 2014
Related Keywords:
- Solid Tumours
- oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability
- Neoplasms
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