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Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Phase 2 trial testing Sorafenib in Carcinoma, Hepatocellular in 125 participants. Completed in 12 October 2016.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 22 October 2009 |
| Primary completion | 14 July 2014 |
| Estimated completion | 12 October 2016 |
| Sites | 28 locations across France, Netherlands, Austria, United Kingdom, Germany, Hungary, Poland, Romania |
Boehringer Ingelheim — full company profile →
18 and older, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Group 1 | 200 | |
| Group 2 | 200 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Phase II, 200 mg Nintedanib Bid | 5.45 | 2.69 – 9.20 |
| Phase II, 400 mg Sorafenib Bid | 4.63 | 2.79 – 20.40 |
Number of patients with dose limiting toxicity are presented
| Group | Value | 95% CI |
|---|---|---|
| Phase I Group I, 100 mg Nintedanib Bid | 0 | |
| Phase I Group 1, 150 mg Nintedanib Bid | 0 | |
| Phase I Group 1, 200 mg Nintedanib Bid | 0 | |
| Phase I Group 2, 50 mg Nintedanib Bid | 0 | |
| Phase I Group 2, 100 mg Nintedanib Bid | 0 | |
| Phase I Group 2, 150 mg Nintedanib Bid | 0 | |
| Phase I Group 2, 200 mg Nintedanib Bid | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Phase II, 200 mg Nintedanib Bid | 1.6 | 0.0 – 8.7 |
| Phase II, 400 mg Sorafenib Bid | 6.5 | 0.8 – 21.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Phase II, 200 mg Nintedanib Bid | 5.32 | 2.69 – 9.20 |
| Phase II, 400 mg Sorafenib Bid | 3.94 | 2.33 – 7.36 |
Overall survival was defined as the duration from date of randomisation to the date of death.
| Group | Value | 95% CI |
|---|---|---|
| Phase II, 200 mg Nintedanib Bid | 11.86 | 6.60 – 25.46 |
| Phase II, 400 mg Sorafenib Bid | 11.40 | 6.51 – 17.25 |
Time frame: From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 1 Group 1, 100mg Nin… | Phase I Group 1, 150mg Nin… | Phase I Group 1, 200mg Nin… | Phase I Group 2, 50mg Nint… | Phase I Group 2, 100mg Nin… | Phase I Group 2, 150mg Nin… | Phase I Group 2, 200mg Nin… | Phase II, 200 mg Nintedani… | Phase II, 400 mg Sorafenib… |
|---|---|---|---|---|---|---|---|---|---|---|
| Hepatic encephalopathy | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — | — | — | — | — | — |
| Hepatic failure | Hepatobiliary disorders | — | — | — | — | — | — | — | — | — |
| Hepatic pain | Hepatobiliary disorders | — | — | — | — | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — | — | — | — | — |
| Splenic vein thrombosis | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Glaucoma | Eye disorders | — | — | — | — | — | — | — | — | — |
| Macular fibrosis | Eye disorders | — | — | — | — | — | — | — | — | — |
| Retinal detachment | Eye disorders | — | — | — | — | — | — | — | — | — |
| Gastric varices haemorrhage | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Reaction | System | Phase 1 Group 1, 100mg Nin… | Phase I Group 1, 150mg Nin… | Phase I Group 1, 200mg Nin… | Phase I Group 2, 50mg Nint… | Phase I Group 2, 100mg Nin… | Phase I Group 2, 150mg Nin… | Phase I Group 2, 200mg Nin… | Phase II, 200 mg Nintedani… | Phase II, 400 mg Sorafenib… |
|---|---|---|---|---|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Lethargy | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Depressed mood | Psychiatric disorders | — | — | — | — | — | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Oedema | General disorders | — | — | — | — | — | — | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Oral candidiasis | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Hepatic encephalopathy, Anaemia, Fatigue, Malignant neoplasm progression, Abdominal pain, Ascites, Diarrhoea, Nausea.
Data from ClinicalTrials.gov NCT01004003 adverse events section.
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
8 peer-reviewed publications reference this trial (live from Europe PMC):
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