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D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01851265
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: Olaparib Other: Dietary Fasted Other: Dietary standard Other: Dietary High Fat Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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.
Actual Study Start Date : July 4, 2013
Actual Primary Completion Date : October 18, 2013
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arms and Interventions
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Arm Intervention/treatment
Fasted
Olaparib capsules following no breakfast
 Drug: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Other: Dietary Fasted
Allocated breakfast prior to dosing with 400mg olaparib capsules
Standard meal
Olaparib capsules after standard breakfast
 Drug: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Other: Dietary standard
Allocated breakfast prior to dosing with 400mg olaparib capsules
High Fat
Olaparib capsules after high fat breakfast
 Drug: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Other: Dietary High Fat
Allocated breakfast prior to dosing with 400mg olaparib capsules


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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)

  2. 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. ]
    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)

  3. 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 ]
    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)

  4. 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. ]
    Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)


Secondary Outcome Measures :
  1. 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 ]
    Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851265


Locations
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Belgium
Research Site
Edegem, Belgium, 2650
Research Site
Leuven, Belgium, 3000
Research Site
Wilrijk, Belgium, 2610
Netherlands
Research Site
Amsterdam, Netherlands, 1081 HV
Research Site
Maastricht, Netherlands, 6202 AZ
United Kingdom
Research Site
Glasgow, United Kingdom, G12 0YN
Research Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Anitra Fielding AstraZeneca Senior Research Physician
Principal Investigator: Christian Rolfo UZ Antwerpen
Study Chair: Wendy Bannister AstraZeneca Study Statistician
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01851265    
Other Study ID Numbers: D081AC00001
2013-001255-13 ( EudraCT Number )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by AstraZeneca:
oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability
Additional relevant MeSH terms:
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Neoplasms
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents