A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.
NCT03553108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-10-01
Summary
This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject.
Conditions
- Malignant Solid Tumor
Interventions
- DRUG
-
Olaparib Treatment A
Olaparib Tablet 25 mg
- DRUG
-
Olaparib Treatment B
Olaparib Tablet 100 mg
- DRUG
-
Olaparib Treatment C
Olaparib Tablet 150 mg
- DRUG
-
Olaparib Treatment D
Olaparib Tablet 250 mg
Sponsors & Collaborators
-
Iqvia Pty Ltd
collaborator INDUSTRY - collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Kevin Punie · Universitaire Aiekenhuizen Leuven
-
Luc Dirix · GZA Ziekenhuizen
-
Guy Jerusalem · Centre Hospitalier Universitaire de Liege
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-16
- Primary Completion
- 2019-03-12
- Completion
- 2020-07-01
Countries
- Belgium
Study Locations
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