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ABT-767

Phase 1

Fallopian Tube | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jan 2, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01339650Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 (BRCA 1 and BRCA 2) Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal CancerPHASE1 COMPLETED 93May 6, 2011Nov 30, 2017Jan 2, 20183 Netherlands
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Study Endpoints
Primary Endpoints
Pharmacokinetic profile
Various time points from Cycle 1 Day -4 to Day 8

Blood samples for pharmacokinetics of ABT-767 will be collected at designated time points

Secondary Endpoints
Safety (number of subjects with adverse events and/or dose limiting toxicities)
Weekly for the first two months, every other week for the third month, and monthly there after. An expected average is 5 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-767EXPERIMENTALABT-767 monotherapy
Interventions
NameTypeDescription
ABT-767DRUGABT-767 once or twice daily for a 28 day cycle
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subjects must have histological or cytological confirmation of locally advanced or metastatic solid tumor, and a documented Breast Cancer Gene 1 or 2 mutation, or high grade serous ovarian, fallopian tube, or primary peritoneal cancer. 3....

Countries:Netherlands
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