Advanced unresectable or metastatic Renal Cell Cancer in patients who have received no previous systemic anti-cancer treatment MedDRA version: 20.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
CAS Number: 656247-18-6
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment. • Histological-confirmed diagnosis of renal cell cancer with clear cell component. • Age = 18 years. • ECOG Performance Score 0 or 1. • Life expectancy of at least 3 months • Must have measurable disease according to RECIST, i.e. presence of at least one target lesion according to RECIST criteria in a previously non-irradiated area. • Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study. • Major injuries, bone fracture and/or surgery within past 4 weeks or/ and planned surgical procedures during the study period. • Hypersensitivity to BIBF 1120, sunitinib or the excipients of the study drugs. • Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 12 months, congestive heart failure > NYHA II, serious cardiac arrhythmia). • LV-EF (left ventricular ejection fraction) by ECHO or MUGA below local limits of normal. • Hepatic function: total bilirubin outside of normal limits; ALT and AST > 1.5x upper limit of normal (ULN) in patients without liver metastasis. For patients with liver metastasis: total bilirubin outside of normal limits, ALT and AST > 2.5x ULN. • Coagulation parameters: international normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN. • Absolute neutrophil count (ANC) 500 ms at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of BIBF 1120 and sunitinib to treat patients with Renal Cell Cancer. An additional objective of the 1199.26 study is to assess the effects of BIBF 1120 treatment on the QTcF interval. ;Secondary Objective: Efficacy • Progression Free Survival. • Objective Tumour response. • Duration of Objective Response. • Overall Survival. • Time to Treatment Failure. • Time to Progression. ECG - BIBF 1120 patients only - Change of the QTcF interval from baseline to each patients maximum dose of BIBF 1120 concentration. - Time averaged QTcF interval over 1 to 12 hours. Safety - Frequency of all Adverse Events, including laboratory parameters, graded by NCI-CTCAEv3. - Dose related dose reductions and discontinuation rates. - Number and duration of hospital stays due to Adverse Events. Pharmacokinetics - PK characteristics of BIBF 1120 after a single dose and at steady state (Day 15).;Primary end point(s): 1. Progression Free Survival in patients treated with either sunitinib or BIBF 1120. 2. For patients treated with BIBF 1120 only - Change from baseline to endpoint (Day 15) of the QTcF interval at each point in time ;Timepoint(s) of evaluation of this end point: 1. 9 months 2. 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression Free Survival. • Objective Response according to the Response Evaluation Criteria in Solid Tumours (RECIST). • Duration of Objective Response. • Overall Survival. • Time to Treatment Failure. • Time to Progression. ;Timepoint(s) of evaluation of this end point: Until last randomised patient stops treatment. | — |
Countries
Hungary, United Kingdom
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH& Co.KG
Outcome results
None listed