NCT02024087

Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

A Phase 1b, Open Label Study of Dalantercept Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The initial design of the study was a dose escalating approach in which dalantercept in combination with sorafenib, would be administered at increasing dose levels among 3 cohorts of subjects with HCC in order to determine the Maximum Tolerated Dose (MTD) of the combination. Once the MTD was determined, a forth expansion cohort of subjects would be enrolled at the MTD to assess safety. A total of up to 38 subjects were planned. The initial cohort (Cohort 1) enrolled 5 subjects at a dalantercept dose level of 0.6 mg/kg once every 3 weeks (Q3W) in combination with sorafenib (400 mg PO once daily). Following an assessment of safety/tolerability by a Safety Review Team, it was recommended to de-escalate the dalantercept dose for Cohort 2 to 0.4 mg/kg Q3W in combination with sorafenib (400 mg PO once daily); 6 subjects were enrolled. The 0.4 mg/kg dose level was determined to be the MTD, and an additional 10 subjects were enrolled at that dose level in the expansion cohort (Cohort 3). A formal Statistical Analysis Plan was initially planned for this study. However, due to its early termination, only cursory descriptive statistics were carried out on the available data; no formal SAP was prepared.

Conditions

• Advanced Adult Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Dalantercept plus sorafenib	Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.

Timeline

• Start date: 2014-08-04
• Primary completion: 2017-07-05
• Completion: 2017-09-22
• First posted: 2013-12-31
• Last updated: 2022-09-26
• Results posted: 2020-12-22

Locations

7 sites across 1 country: United States