Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: BIBF 1120; Drug: Sorafenib

• Registration Number: NCT01004003
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-12
• Study Start: 2009-10-22
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2014-07-14
• Disposition First Submitted: 2014-08-18
• Disposition First Submitted QC: 2014-08-18
• Disposition First Posted: 2014-08-20
• Results First Submitted: 2015-07-09
• Results First Submitted QC: 2015-07-09
• Results First Posted: 2015-08-07
• Study Completion: 2016-10-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBF 1120	BIBF 1120	Phase I dose escalation and phase II using dose determined in phase I ( 200 mg BID)
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose in Phase I	4 weeks	The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.
Time to Progression (TTP) in Phase II	From randomization until data cut-off (15 July 2014); Up to 1031 days	TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.

Secondary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicity in Phase I	4 weeks	Number of patients with dose limiting toxicity are presented
Objective Tumour Response by RECIST	From randomization until data cut-off (15 July 2014); Up to 1031 days	Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.; 95% Confidence Interval presented below are computed by Clopper and Pearson method.
Progression Free Survival (PFS)	From randomization until data cut-off (15 July 2014); Up to 1031 days	PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.
Overall Survival	From randomization until data cut-off (15 July 2014); Up to 1031 days	Overall survival was defined as the duration from date of randomisation to the date of death.

Trial Locations

Locations (28)

1199.37.33002 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1199.37.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 München, Germany

1199.37.48003 Boehringer Ingelheim Investigational Site; 🇵🇱 Warsaw, Poland

1199.37.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Edgbaston, Birmingham, United Kingdom

1199.37.44005 Boehringer Ingelheim Investigational Site; 🇬🇧 Glasgow, United Kingdom

1199.37.44002 Boehringer Ingelheim Investigational Site; 🇬🇧 London, United Kingdom

1199.37.44003 Boehringer Ingelheim Investigational Site; 🇬🇧 London, United Kingdom

1199.37.44006 Boehringer Ingelheim Investigational Site; 🇬🇧 Manchester, United Kingdom

1199.37.44004 Boehringer Ingelheim Investigational Site; 🇬🇧 Nottingham, United Kingdom

1199.37.48001 Boehringer Ingelheim Investigational Site; 🇵🇱 Warszawa, Poland

1199.37.44008 Boehringer Ingelheim Investigational Site; 🇬🇧 Liverpool, United Kingdom

1199.37.43002 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1199.37.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Freiburg, Germany

1199.37.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Jena, Germany

1199.37.36001 Boehringer Ingelheim Investigational Site; 🇭🇺 Debrecen, Hungary

1199.37.48002 Boehringer Ingelheim Investigational Site; 🇵🇱 Olsztyn, Poland

1199.37.40002 Boehringer Ingelheim Investigational Site; 🇷🇴 Bucharest, Romania

1199.37.49008 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1199.37.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Magdeburg, Germany

1199.37.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Tübingen, Germany

1199.37.40003 Boehringer Ingelheim Investigational Site; 🇷🇴 Cluj-Napoca, Romania

1199.37.33001 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1199.37.49009 Boehringer Ingelheim Investigational Site; 🇩🇪 Erlangen, Germany

1199.37.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Hannover, Germany

1199.37.49010 Boehringer Ingelheim Investigational Site; 🇩🇪 Heidelberg, Germany

1199.37.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Leiden, Netherlands

1199.37.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Utrecht, Netherlands

1199.37.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria