A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.

Sponsor
AstraZeneca
Study ID
NCT03553108
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 16, 2018
Status verified
Sep 2020
Primary completion
Mar 12, 2019
Completion
Jul 1, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib Treatment Sequence ABCD
    On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. A - Olaparib Tablet 25 mg B - Olaparib Tablet 100 mg C - Olaparib Tablet 150 mg D - Olaparib Tablet 250 mg
  • Experimental: Olaparib Treatment Sequence BDAC
    On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. B - Olaparib Tablet 100 mg D - Olaparib Tablet 250 mg A - Olaparib Tablet 25 mg C - Olaparib Tablet 150 mg
  • Experimental: Olaparib Treatment Sequence CADB
    On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. C - Olaparib Tablet 150 mg A - Olaparib Tablet 25 mg D - Olaparib Tablet 250 mg B - Olaparib Tablet 100 mg
  • Experimental: Olaparib Treatment Sequence DCBA
    On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. D - Olaparib Tablet 250 mg C - Olaparib Tablet 150 mg B - Olaparib Tablet 100 mg A - Olaparib Tablet 25 mg

Primary Outcome Measure

%PECmax [ Time Frame: 0 to 72 hours ]

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