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AZD3965

Phase 1

Adult Solid Tumor | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 11, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01791595A Phase I Trial of AZD3965 in Patients With Advanced CancerPHASE1 COMPLETED 53Apr 23, 2013Nov 17, 2020Apr 11, 20227 United Kingdom
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Study Endpoints
Primary Endpoints
MTD of AZD3965
Day -7 to Day 28

MTD was determined by testing increasing AZD3965 doses in Part 1 dose escalation cohorts (Cohorts 1-6) and defined as the total daily dose level below that at which ≥2 out of ≤6 evaluable patients had a dose-limiting toxicity (DLT) during Cycle 1 (including Day -7). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)

Number of Patients Who Experienced DLTs
Day -7 to Day 28

Number of patients who experienced protocol-defined DLTs (defined according to NCI CTCAE version 4.02). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)

Number of Patients Who Experienced Serious AEs
From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days)

A serious adverse event (SAE) is any AE, regardless of dose, causality or expectedness, that results in death, is life-threatening, requires in-patient hospitalisation or prolongs existing in-patient hospitalisation, results in persistent or significant incapacity or disability, is a congenital anomaly or birth defect or is any other medically important event. Any ophthalmic and/or cardiac DLT is considered a medically important event and therefore an SAE in this trial. Specific AE terms are provided in the Adverse Events section

Number of Patients Who Experienced Non-Serious AEs
From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days)

A non-serious AE is any untoward medical occurrence that does not meet the serious criteria described for outcome measure 3 above. Specific AE terms are provided in the Adverse Events section

Secondary Endpoints
Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Post AZD3965 Dosing
Part 1 (Cohorts 1-4): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose)
AUC From 0 to 12 Hours Post AZD3965 Dosing
Part 1 (Cohorts 5-6): Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 12 hours post-dose)
Maximum Observed Plasma Concentration of AZD3965
Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose), Day 1 & 29 (each pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]); Part 2 (Expansion): Day 1 (pre-dose; 4, 6, 12 hours post-dose)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD3965 Cohort 1 (5 mg OD)EXPERIMENTAL -
AZD3965 Cohort 2 (10 mg OD)EXPERIMENTAL -
AZD3965 Cohort 3 (20 mg OD)EXPERIMENTAL -
AZD3965 Cohort 4 (30 mg OD)EXPERIMENTAL -
AZD3965 Cohort 5 (15 mg BD)EXPERIMENTAL -
AZD3965 Cohort 6 (10 mg BD)EXPERIMENTAL -
AZD3965 Expansion Cohort (10 mg BD)EXPERIMENTAL -
Interventions
NameTypeDescription
AZD3965DRUGDay -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Part 1: * Histologically or cytologically proven advanced solid tumour or lymphoma, refractory to conventional treatment or for which no conventional therapy exists. * Available archived tumour samples. Part 2: * Histologically proven DLBCL or BL, which is relap...

Countries:United Kingdom
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