Clinical trial · Interventional
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Fasted | Other | — | UNRESOLVED |
| Dietary High Fat | Other | — | UNRESOLVED |
| Dietary standard | Other | — | UNRESOLVED |
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Fasted
- description
- Olaparib capsules following no breakfast
- interventionNames
- Drug: Olaparib
- Other: Dietary Fasted
- type
- OTHER
- label
- Standard meal
- description
- Olaparib capsules after standard breakfast
- interventionNames
- Drug: Olaparib
- Other: Dietary standard
- type
- OTHER
- label
- High Fat
- description
- Olaparib capsules after high fat breakfast
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available