Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
研究概览
简要总结
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.
Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with advanced solid tumours who have completed a previous study with BIBF
- •The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF
- •Age 18 years or older
- •Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
- •Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)
排除标准
- •Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
- •Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
- •Active ulcers (gastro-intestinal tract, skin)
- •Major injuries and surgery within the past three weeks with incomplete wound healing
- •Hypersensitivity to BIBF 1120 or the excipients of the trial drug
- •Known secondary malignancy requiring therapy
- •Active infectious disease
- •Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
- •Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- •Brain metastases requiring therapy
- •Absolute neutrophil count less than 1,500/mm3
- •Platelet count less than 100,000/mm3
- •Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
- •Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
- •Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
- •Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
- •Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
- •Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- •Pregnancy or lactation
- •Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
- •Patients unable to comply with the protocol
- •Active alcohol or drug abuse
结局指标
主要结局
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
时间窗: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
时间窗: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Difference From Baseline for Bilirubin, Creatinine and Glucose
时间窗: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
时间窗: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
时间窗: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Difference From Baseline for Haematology and Differentials Parameters
时间窗: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Liver Enzymes
时间窗: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Coagulation Parameters
时间窗: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
时间窗: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Difference From Baseline for Haemoglobin
时间窗: From baseline until end of treatment, up to 991 days
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Electrolytes
时间窗: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
次要结局
- Clinically Relevant Abnormalities for Vital Signs(From baseline until final follow-up, up to 991 days)
- Confirmed Objective Response(Baseline until end of treatment, up to 991 days)
- Unconfirmed Best Overall Response(Baseline until end of treatment, up to 991 days)
- Unconfirmed Best Objective Response(Baseline until end of treatment, up to 991 days)
- Clinical Benefit(Baseline until end of treatment, up to 991 days)
- Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)(Just before drug administration every 28±7 days after day 29)
- Progression Free Survival(First drug administration (in previous trial) until end of treatment, up to 1230 days)