Clinical trial NCT02828124: A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer
Official title: A Phase 1/2 Study of BMS-986183 in Subjects With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have advanced liver cancer that cannot be treated with surgery or other local methods
* Liver cancer is confirmed by a microscopic examination of tissue
* Liver disease is classified as 'A' by a standard method called Child-Pugh score
* Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
* Women must use contraception

Exclusion Criteria:

* Prior liver transplant
* Increase in blood pressure in some of the veins entering the liver
* Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
* Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
* Disease of the heart or blood vessels around the heart
* Active cancers within the last 2 years
* No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
* Currently on anti-platelet or anti-coagulation therapy
* Radiotherapy within 4 weeks of treatment
* Any major allergies

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of Adverse Events at Its Worst Grade
timeFrame: First dose up to approximately 24 months
measure: Incidence of Serious Adverse Events at Its Worst Grade
timeFrame: First dose up to approximately 24 months
measure: Incidence of Adverse Events Leading to Discontinuation
timeFrame: First dose up to approximately 24 months
measure: Incidence of Adverse Events Leading to Death
timeFrame: First dose up to approximately 24 months
measure: Incidence of Laboratory Test Toxicity Grade Shifting From Baseline
timeFrame: First dose up to approximately 24 months
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: First dose up to approximately 24 months
measure: Overall Response Rate (ORR)
timeFrame: First dose up to approximately 24 months
measure: Duration of Response (DoR)
timeFrame: First dose up to approximately 24 months
measure: Progression Free Survival (PFS)
timeFrame: First dose up to approximately 24 months
measure: PFS Rate at Week 't'
timeFrame: First dose up to approximately 24 months
measure: Maximum Observed Concentration (Cmax)
timeFrame: From first does up to approximately 24 months
measure: Time of Maximum Observed Concentration (Tmax)
timeFrame: First dose up to approximately 24 months
measure: Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)]
timeFrame: First does up to appromimately 24 months
measure: Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
timeFrame: First dose up to approximately 24 months
measure: Concentration at the End of a Dosing Interval (Ctau)
timeFrame: First dose up to approximately 24 months
measure: Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough)
timeFrame: First dose up to approximately 24 months
measure: Total Body Clearance (CLT)
timeFrame: First dose to approximately 24 months
measure: Apparent Volume of Distribution at Steady-state (Vss)
timeFrame: First dose up to approximately 24 months
measure: Volume of Distribution of Terminal Phase (Vz)
timeFrame: First dose up to approximately 24 months
measure: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax)
timeFrame: First dose up to approximately 24 months
measure: Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau)
timeFrame: First dose up to approximately 24 months
measure: Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)]
timeFrame: First dose up to approximately 24 months
measure: Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave)
timeFrame: First dose up to approximately 24 months
measure: Terminal Half-life (T-HALF)
timeFrame: First dose up to approximately 24 months
measure: Changes in QTcF (ΔQTcF) From Baseline
timeFrame: Baseline up to approximately 24 months
measure: Incidence of Positive Anti-drug Antibody (ADA)
timeFrame: First dose up to approximately 24 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: