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Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours
A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.
Study details:
A Phase I open-label, multicentre study to determine the RP2D of olaparib monotherapy in the paediatric population, and to evaluate the safety, tolerability, PK, PDx and preliminary efficacy of olaparib monotherapy in paediatric patients from ≥6 months to \<18 years of age at enrolment, with relapsed or refractory solid or primary CNS tumours (excluding lymphoid malignancies) for whom there are no standard treatment options. It is anticipated that eligible patients fulfilling all of the inclusion criteria and none of the exclusion criteria, will include but will not be limited to those with osteosarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-01-14
Primary completion: 2024-10-31
Study completion finish: 2024-10-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04236414
Intervention or treatment
DRUG: Olaparib
Conditions
- • Solid Tumours
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Clayton, Not Specified, Australia
Research Site
Nedlands, Not Specified, Australia
Research Site
Randwick, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort A: ≥12 to <18 years
| DRUG: Olaparib
|
EXPERIMENTAL: Cohort B: ≥3 to <12 years
| DRUG: Olaparib
|
EXPERIMENTAL: Cohort C: ≥6 months to <6 years
| DRUG: Olaparib
|
EXPERIMENTAL: Signal identification
| DRUG: Olaparib
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Dose limiting toxicity [DLTs] | DLT - Dose limiting toxicity | 28 days |
Safety profile | Number of patients with adverse events | Until 30 days after last dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Apparent total clearance of the drug from plasma at steady state after oral administration [CLss/F] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Maximum plasma concentration at steady state [Css,max] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Minimum plasma concentration at steady state [Css, min] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Time to maximum plasma concentration at steady state [tss,max] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Area under the curve at steady state [AUCss] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Dose normalised area under the curve at steady state [dose normalised AUCss] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Area under the curve at 0-8 hours [AUC(0-8)] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Area under the curve from zero up to time t [AUC0-t] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
Dose normalised maximum plasma concentration at steady state [dose normalised Css,max] | Olaparib levels in mcg/mL | The pre-dose sample should be collected within 12±0.5 hours of the Day 7 evening dose of olaparib, prior to the Day 8 morning dose and within 12±1 hours of the Day 28 evening olaparib dose, prior to the Day 29 morning dose. |
ORR as defined by Investigator-assessed RECIST v1.1, INRC or RANO | ORR - Objective response rate INRC - International Neuroblastoma Response Criteria RECIST - Response Evaluation Criteria in Solid tumours RANO - Response Assessment in Neuro-oncology | Up to 64 months |
DCR as defined by Investigator-assessed RECIST v1.1, INRC or RANO | DCR - Disease control rate INRC - International Neuroblastoma Response Criteria RECIST - Response Evaluation Criteria in Solid tumours RANO - Response Assessment in Neuro-oncology | Up to 64 months |
DoR as defined by Investigator-assessed RECIST v1.1, INRC or RANO | DoR - Duration of response INRC - International Neuroblastoma Response Criteria RECIST - Response Evaluation Criteria in Solid tumours RANO - Response Assessment in Neuro-oncology | Up to 64 months |
Frequently Asked Questions
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