Recent Updates
Recently added Catalysts

Olaparib Treatment A

Phase 1

Malignant Solid Tumor | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Oct 1, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03553108A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.PHASE1 COMPLETED 18 — — May 16, 2018Jul 1, 2020Oct 1, 20203 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
%PECmax
0 to 72 hours

Percent prediction error for Cmax

%PEAUC
0 to 72 hours

Percent prediction error for AUC

Secondary Endpoints
Maximum plasma concentration (Cmax) obtained directly from the observed concentration versus time data.
Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Time to maximum plasma concentration (tmax) obtained directly from the observed concentration versus time data.
Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) calculated by linear up/log down trapezoidal summation.
Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Olaparib Treatment Sequence ABCDEXPERIMENTALOn 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
Olaparib Treatment Sequence BDACEXPERIMENTALOn 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
Olaparib Treatment Sequence CADBEXPERIMENTALOn 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
Olaparib Treatment Sequence DCBAEXPERIMENTALOn 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
Interventions
NameTypeDescription
Olaparib Treatment ADRUGOlaparib Tablet 25 mg
Olaparib Treatment BDRUGOlaparib Tablet 100 mg
Olaparib Treatment CDRUGOlaparib Tablet 150 mg
Olaparib Treatment DDRUGOlaparib Tablet 250 mg
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Female or male subject, aged \> 18 years. 3. Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy for which no suitable effecti...

Countries:Belgium
Unlock Eligibility Criteria