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ABT-767

Phase 1

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

ABT-767 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

ABT-767 clinical trials

ABT-767 · 1 trial · 3 indications

Phase 1 1
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 CancerFallopian Tube
COMPLETED93 Analytics
PHASE1COMPLETED
Study 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 Cancer
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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 to 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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Frequently asked questions about ABT-767

What is ABT-767 used for?

ABT-767 is an investigational small molecule studied in oncology for high grade serous ovarian, fallopian tube, or primary peritoneal cancer, as well as other solid tumors. It was evaluated in patients with BRCA1 and BRCA2 mutations. It is not an approved therapy and remains in clinical development.

Who is developing ABT-767?

ABT-767 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the clinical research program for this small molecule oncology candidate.

What phase is ABT-767 in?

ABT-767 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials is ABT-767 in?

ABT-767 was studied in a single Phase 1 trial, NCT01339650, titled Study of ABT-767 in Subjects With BRCA 1 and BRCA 2 Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The trial enrolled 93 patients in the Netherlands and is completed.

Was the ABT-767 trial randomized or blinded?

The Phase 1 trial of ABT-767, NCT01339650, was an uncontrolled study. It was not randomized and not double blinded. It enrolled 93 patients with BRCA1 or BRCA2 mutations and solid tumors or high grade serous ovarian, fallopian tube, or primary peritoneal cancer.

Was ABT-767 studied in biomarker-selected patients?

Yes. The ABT-767 Phase 1 trial NCT01339650 enrolled patients selected for BRCA1 and BRCA2 mutations, alongside solid tumors or high grade serous ovarian, fallopian tube, or primary peritoneal cancer. Biomarker selection was part of the study design.