Antineoplastic Agents

All Drugs and Chemicals

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

BIBF 1120

Boehringer Ingelheim

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.

A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

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).

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).

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).

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).

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 (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 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 (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.

Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29

Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).

PD = Progressive disease.

Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)

Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).

Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)

Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.

PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.

Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.

Boehringer Ingelheim, Study Chair

Patients were treated with 50 mg Nintedanib once daily in the morning.

50mg QD

Patients were treated with 200 mg Nintedanib once daily in the morning.

200mg QD

Patients were treated with 100 mg Nintedanib twice daily.

100mg BID

Patients were treated with 150 mg Nintedanib twice daily.

150mg BID

Patients were treated with 200 mg Nintedanib twice daily.

200mg BID

Patients were treated with 250 mg Nintedanib twice daily.

250mg BID

Patients were treated with 300 mg Nintedanib twice daily.

300mg BID

Total

Age, Continuous

Sex: Female, Male

Treated set which comprised of all patients who received at least one dose of Nintedanib in both their previous Nintedanib trial and in this extension trial

Boehringer Ingelheim Call Center

Dyspepsia

Fatigue

Nasopharyngitis

Anorexia

Hyperhidrosis

Diarrhoea

Bronchitis

Eye disorder

Eyelid oedema

Haemorrhoids

Toothache

Pyrexia

Muscle spasms

Neck pain

Pain in extremity

Vulvovaginal dryness

Arrhythmia

Nausea

Vomiting

Abdominal pain

Gastrooesophageal reflux disease

Tooth discolouration

Asthenia

Xerosis

Gastrointestinal infection

Bone pain

Arthralgia

Musculoskeletal chest pain

Myalgia

Dizziness

Headache

Anxiety

Rales

Nail disorder

Rash

Hot flush

Vertigo

Constipation

Flatulence

Gastric disorder

Hypersensitivity

Viral infection

Musculoskeletal pain

Balance disorder

Carpal tunnel syndrome

Sciatica

Dysuria

Dyspnoea

Rash maculo-papular

Sinus tachycardia

Eye pain

Visual impairment

Abdominal distension

Gastrointestinal haemorrhage

Adverse drug reaction

Chest pain

Chills

Hepatic pain

Urinary tract infection

Weight decreased

Hyperglycaemia

Muscular weakness

Back pain

Joint swelling

Dysgeusia

Peripheral sensory neuropathy

Insomnia

Haematuria

Incontinence

Cough

Alopecia

Dry skin

Pruritus

Conjunctivitis

Haemoptysis

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1

Clinically Relevant Abnormalities for Vital Signs

Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.

Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)

Complete response

Partial response

Stable disease

Non-evaluable, clinically non-progressive disease

PD or non-evaluable , clinically PD

Unknown

Unconfirmed Best Overall Response

Unconfirmed Best Objective Response

Clinical Benefit

Confirmed Objective Response

Progression (RECIST)

Death

No progressive disease (RECIST) or death

Progression Free Survival

Osteoarthritis

Parotitis

Osteolysis

Abdominal pain upper

Gastrointestinal disorder

Groin pain

Anaemia

Neutropenia

Oedema peripheral

Gamma-glutamyltransferase increased

Dehydration

Productive cough

Deep vein thrombosis

Phlebitis superficial

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2

Diarrhoea infectious

Lymphopenia

Ileus

Subileus

Pneumonia

Convulsion

Renal failure

Urinary tract obstruction

Pleural effusion

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4

Subdural Haematoma

Malignant neoplasm progression

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5

Alkaline phosphatase

Aspartate aminotransferase

Alanine aminotransferase

Difference From Baseline for Liver Enzymes

Bilirubin (total)

Creatinine

Glucose (N=1,1,3,9,4,14,1)

Difference From Baseline for Bilirubin, Creatinine and Glucose

Difference From Baseline for Haemoglobin

Platelets

White blood cell count

Lymphocytes (N=1,1,4,9,4,17,1)

Neutrophils (N=1,1,4,9,6,17,1)

Difference From Baseline for Haematology and Differentials Parameters

PT-INR (N=1,1,3,7,5,14,1)

Partial thromboplastin time (N=1,1,3,9,4,14,1)

Difference From Baseline for Coagulation Parameters

Potassium (N=1,1,4,9,6,18,1)

Sodium (N=1,1,4,9,6,18,1)

Difference From Baseline for Electrolytes

Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.

Patients were treated with 100 mg Nintedanib twice daily (BID).

Overall Study

Spots Global Cancer Trial Database for A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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