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ABI-008

Phase 1

Hormone Refractory Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 22, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

ABI-008 · 1 trial · 1 indication

Phase 1 1
NCT00477529ABI-008 Trial in Patients With Hormone-refractory Prostate CancerHormone Refractory Prostate Cancer
COMPLETED102 Analytics
PHASE1COMPLETED
ABI-008 Trial in Patients With Hormone-refractory Prostate Cancer
Hormone Refractory Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

DLT's and MTD's
1 Year

Secondary Endpoints

Efficacy of ABI-008 in this patient population
Q12 weeks and End of Study (EOS) and Follow Up
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABI-008EXPERIMENTAL -

Interventions

NameTypeDescription
ABI-008DRUGnab-docetaxel
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study. 1. Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is clinically refractory to hormone therapy. 2. Zubrod Performance Status 0-1. 3. At the time of enrol...

Countries:United States
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Frequently asked questions about ABI-008

What is ABI-008 used for?

ABI-008 is an investigational small molecule being studied for the treatment of hormone refractory prostate cancer, a form of prostate cancer that no longer responds to hormone therapy. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does ABI-008 target?

The molecular target of ABI-008 has not been disclosed. It is a small molecule modality being investigated for its potential activity in hormone refractory prostate cancer. The specific biological pathway it acts on has not been publicly detailed.

Who makes ABI-008?

ABI-008 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is ABI-008 in?

ABI-008 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, but the drug remains in early-stage clinical testing and is not yet available as a marketed therapy.

What clinical trials is ABI-008 in?

ABI-008 has been studied in one completed Phase 1 clinical trial, identified as NCT00477529. This trial enrolled 102 male patients with hormone refractory prostate cancer in the United States. The study was uncontrolled, meaning there was no comparator arm, and it was not randomized or double-blinded.

Is ABI-008 the same as abiraterone?

ABI-008 is not the same as abiraterone. Abiraterone is a different drug, marketed under brand names such as Zytiga, and is approved for prostate cancer. ABI-008 is a separate investigational compound with a distinct chemical identity, developed by Bristol-Myers Squibb.