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TGF-beta inhibitor
Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Acceleron Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 20 weeks
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to evaluate the safety and tolerability of dalantercept plus sorafenib in patients with advanced hepatocellular carcinoma (HCC) to determine the recommended dose level of dalantercept in combination with sorafenib.
Eligible Conditions
- Liver Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Secondary study objectives
Best Overall Response
Disease Control Rate (DCR)
Overall Survival (OS)
Side effects data
From 2017 Phase 1 & 2 trial • 21 Patients • NCT0202408738%
abdominal pain
25%
peripheral oedema
19%
leukopoenia
13%
asthenia
6%
atrial fibrillation
6%
hypoglycaemia
6%
haemoptysis
6%
pulmonary oedema
6%
pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dalantercept 0.4 mg/kg Plus Sorafenib
Dalantercept 0.6 mg/kg Plus Sorafenib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Expansion cohort - dalantercept 0.4 mg/kg plus sorafenib 400 mgExperimental Treatment1 Intervention
Cohort 3: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily
Group II: Dalantercept 0.6 mg/kg plus sorafenib 400 mgExperimental Treatment1 Intervention
Cohort 1: Participants received dalantercept 0.6 mg/kg by subcutaneous (SC) injection once every 3 weeks plus sorafenib 400 mg orally (PO) once daily
Group III: Dalantercept 0.4 mg/kg plus sorafenib 400 mgExperimental Treatment1 Intervention
Cohort 2: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Find a Location
Who is running the clinical trial?
Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
3,024 Total Patients Enrolled
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
32 Previous Clinical Trials
4,246 Total Patients Enrolled
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor
32 Previous Clinical Trials
4,246 Total Patients Enrolled