Compare safety and efficacy of BIBF 1120 versus sunitinib

Phase 1

• Conditions: Advanced unresectable or metastatic Renal Cell Cancer in patients who have received no previous systemic anti-cancer treatment; MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-009516-44-GB
• Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-01
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 < 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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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) < 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 anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg 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