Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01004003|
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : August 7, 2015
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Sorafenib Drug: BIBF 1120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.|
|Actual Study Start Date :||October 22, 2009|
|Actual Primary Completion Date :||July 14, 2014|
|Actual Study Completion Date :||October 12, 2016|
Experimental: BIBF 1120
Phase I dose escalation and phase II using dose determined in phase I ( 200 mg BID)
Drug: BIBF 1120
Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data
|Active Comparator: Sorafenib||
- Maximum Tolerated Dose in Phase I [ Time Frame: 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 [ Time Frame: 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.
- Incidence of Dose Limiting Toxicity in Phase I [ Time Frame: 4 weeks ]Number of patients with dose limiting toxicity are presented
- Objective Tumour Response by RECIST [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004003
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|