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Best Standard of Care

Phase 3

Carcinoma, Hepatocellular | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Jun 2, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment397

FDA Designations

No designations recorded

Clinical trial landscape

Best Standard of Care · 1 trial · 1 indication

Phase 3 1
NCT01655693Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular CarcinomaCarcinoma, Hepatocellular
COMPLETED397 Analytics
PHASE3COMPLETED
Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma
Carcinoma, HepatocellularUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
Time from date of randomization to the date of death from any cause with initial assessment up to 24 months and follow-up assessment up to 45 months.

OS is defined as the time from date of randomization to the date of death from any cause.

Secondary Endpoints

Progression-free Survival (PFS)
Time from date of randomization to date of first documented progression or death from any cause, which ever came first, assessed up to 20 months.
Objective Response Rate (ORR)
Time from date of first treatment cycle to date of last cycle of treatment for the full duration of study treatment up to 24 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Doxorubicin Transdrug (DT) at 20 mg/m2EXPERIMENTALDT will be infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and will be repeated every 4 weeks until disease progression or unacceptable toxicity
Doxorubicin Transdrug (DT) at 30 mg/m2EXPERIMENTALDT will be infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and will be repeated every 4 weeks until disease progression or unacceptable toxicity
Best Standard of CareACTIVE_COMPARATORPatients randomized in the control group will receive treatment according to the investigator's choice, until disease progression or unacceptable toxicity

Interventions

NameTypeDescription
Doxorubicin 20 mg/m2DRUG -
Doxorubicin 30 mg/m2DRUG -
Best Standard of CareDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites70

Inclusion Criteria: * Male or non-pregnant, non-breast feeding female; * Aged ≥ 18 years; * Patient with: * advanced HCC (BCLC-C according to BCLC staging classification) having progressed under Sorafenib therapy or intolerant to Sorafenib, or; * intermediate HCC (BCLC-B) non eligible or non r...

Countries:United StatesAustriaBelgiumEgyptFranceGermanyHungaryItalyLebanonSpainTurkey (Türkiye)
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Frequently asked questions about Best Standard of Care

What is Best Standard of Care used for?

Best Standard of Care is used for the treatment of hepatocellular carcinoma, a type of liver cancer. It is being studied in patients with advanced hepatocellular carcinoma. The drug is in Phase 3 clinical development and is being developed by cbdMD, Inc. (YCBD).

Who makes Best Standard of Care?

Best Standard of Care is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The drug is currently in Phase 3 clinical development for the treatment of hepatocellular carcinoma, a form of liver cancer.

What phase is Best Standard of Care in?

Best Standard of Care is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of advanced hepatocellular carcinoma. The Phase 3 trial has been completed, and the drug is not yet approved by regulatory authorities.

What clinical trials is Best Standard of Care in?

Best Standard of Care has one completed Phase 3 clinical trial, identified as NCT01655693. This study, titled 'Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma,' enrolled 397 participants and was conducted in multiple countries including the United States, Austria, Belgium, Egypt, France, Germany, Hungary, Italy, Lebanon, Spain, and Turkey.

Is Best Standard of Care FDA approved?

Best Standard of Care is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of advanced hepatocellular carcinoma. The Phase 3 trial has been completed, but the drug has not yet received regulatory approval.

Is Best Standard of Care a randomized controlled trial?

Yes, the Phase 3 clinical trial for Best Standard of Care, NCT01655693, was randomized and active-controlled. The study enrolled 397 participants with advanced hepatocellular carcinoma and was conducted across multiple countries. The trial has been completed.