A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872014
• Other study ID #: 20080580
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2009
• Last updated: February 5, 2016
• Start date: August 2009
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeFrance:CNOM: National Council of the French Medical AssociationGermany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy.

Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.

Description:

The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced or inoperable HCC

• Child-Pugh A liver function score

• Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications

• Adequate organ and hematological function

• Men or women greater than or equal to 18 years old

• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria:

• Subject is eligible for a liver transplant per investigators discretion

• Any previous systemic chemotherapy for HCC

• History of arterial or venous thromboembolism within 12 months prior to enrollment

• History of clinically significant bleeding within 6 months prior to enrollment

• History of central nervous system metastases

• Clinically significant cardiovascular disease within 12 months

• Uncontrolled hypertension

• Subjects with a history of prior malignancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Inoperable Hepatocellular Carcinoma

Intervention

Drug:
• AMG 386
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
• AMG 386
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
• Sorafenib
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) rate at 4 months		4 months	No
Secondary	Incidence of adverse events and significant laboratory abnormalities		Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks	Yes
Secondary	Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression		Radiologic imaging every 8 weeks	No
Secondary	Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib		Weeks 1, 2, 5, 9, and every 16 weeks thereafter	No
Secondary	Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386		Weeks 2, 5, 9, and every 16 weeks thereafter	No
Secondary	Incidence of the occurrence of anti-AMG 386 antibody formation		Weeks 1, 5, 9, and every 16 weeks thereafter	No
Secondary	Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers		Weeks 1, 2, 5, and every 16 weeks thereafter	No

External Links

•   AmgenTrials clinical trials website