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ABT-414

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

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 Enrollment202
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01800695Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma MultiformePHASE1 COMPLETED 202 — — Apr 2, 2013Jun 19, 2017Nov 21, 2017 - —
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Study Endpoints
Primary Endpoints
Number and percentage of participants with adverse events
Every week for an expected average of 34 weeks

Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

Maximum concentration of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the maximum concentration of ABT- 414 in the blood

Number of Dose Limiting Toxicities
Every week for an expected average of 34 weeks

Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

Minimum Concentration of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the minimum concentration of ABT-414 in the blood

Half-life of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the clearance of ABT-414

Secondary Endpoints
Biomarker EGFR expression
At screening and post-study
Progression Free Survival
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Overall Survival
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALABT-414 in combination with radiation and temozolomide
Arm BEXPERIMENTALABT-414 in combination with temozolomide
Arm CEXPERIMENTALABT-414 monotherapy
Interventions
NameTypeDescription
ABT-414DRUGABT-414 will be administered by intravenous infusion
TemozolomideDRUGTemozolomide will be administered per label and local prescribing regulations.
Whole Brain RadiationRADIATIONWhole Brain radiation will be administered in 30 fractions.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Glioblastoma Multiforme (GBM) 2. 70 or above on Karnofsky Performance Status 3. Adequate bone marrow function 4. Recurrent GBM per RANO criteria 5. Subjects must have confirmed EGFR amplification by central lab Exclusion Criteria: 1. For Subjects with recurrent GBM in Arm B...

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