A randomised, open label, parallel group Phase II study comparing theefficacy and tolerability of BIBF 1120 versus sunitinib in previouslyuntreated patients with Renal Cell Cancer. - BIBF 1120 in 1st line Renal Cell Carcinoma
- Conditions
- Advanced unresectable or metastatic Renal Cell Cancer in patients who have received no previous systemic anticancertreatment.MedDRA version: 12.0Level: LLTClassification code 10050513Term: Metastatic renal cell carcinoma
- Registration Number
- EUCTR2009-009516-44-HU
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
• 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 < 2 x ULN.
• Written informed consent consistent with ICH-GCP guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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) < 1500/ml, Platelets <100000/ml,
Haemoglobin <9.0 g/dl.
• History of clinically significant haemorrhagic or thromboembolic event in
the past 6 months.
• Known inherited predisposition to bleeds or to thrombosis.
• History of clinically significant haemoptysis within the last 3 months (more
than one tea-spoon of fresh blood per day)
• Therapeutic anticoagulation (except low-dose heparin and/or heparin flush
as needed for maintenance of an in-dwelling intravenous device) or antiplatelet
therapy (except for low-dose therapy with acetylsalicylic acid
< 325mg per day).
• Previous treatment for RCC with targeted agents (in particular including
any antibody and any VEGF/VEGFR, EGFR and mTOR inhibitors),
immunotherapy [Interferon (IFNa) or Interleukin-2 (IL-2)] or chemotherapy.
• Treatment with other investigational drugs or participation in another
clinical study within the past 4 weeks before start of therapy or
concomitantly with this study.
• Patients unable to comply with the protocol.
• Pregnancy or breast feeding.
• Active alcohol or drug abuse.
• Women of child bearing potential, or men who are able to father a child,
unwilling to use a medically acceptable form of contraception during the
study period.
• Symptomatic central nervous system (CNS) metastatis or leptomeningeal
disease as documented by CT, MRI or analysis of cerebrospinal fluid
requiring radiotherapy, steroids or anticonvulsive treatment.
• Radiotherapy within the previous 4 weeks.
• QTcF interval > 500 ms at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method