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

NCT00715403 | Completed Phase 1 Results

• 1 other identifier: 1199.16
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (11)

• Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1

  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).

  From signing the informed consent until final follow-up, up to 991 days

• Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2

  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).

  From signing the informed consent until final follow-up, up to 991 days

• Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3

  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).

  From signing the informed consent until final follow-up, up to 991 days

• Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4

  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).

  From signing the informed consent until final follow-up, up to 991 days

• Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5

  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).

  From signing the informed consent until final follow-up, up to 991 days

• Difference From Baseline for Liver Enzymes

  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.

  From signing the informed consent until end of treatment, up to 991 days

• Difference From Baseline for Bilirubin, Creatinine and Glucose

  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.

  From signing the informed consent until end of treatment, up to 991 days

• Difference From Baseline for Haemoglobin

  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.

  From baseline until end of treatment, up to 991 days

• Difference From Baseline for Haematology and Differentials Parameters

  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.

  From signing the informed consent until end of treatment, up to 991 days

• Difference From Baseline for Coagulation Parameters

  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.

  From signing the informed consent until end of treatment, up to 991 days

• Difference From Baseline for Electrolytes

  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.

  From signing the informed consent until end of treatment, up to 991 days

Secondary Outcomes (7)

• Clinically Relevant Abnormalities for Vital Signs

  From baseline until final follow-up, 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

• 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

Interventions

BIBF 1120 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. 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 1120.
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (11)

1199.16.3306A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1199.16.3311A Boehringer Ingelheim Investigational Site

Clichy, France

Location

1199.16.3311B Boehringer Ingelheim Investigational Site

Clichy, France

Location

1199.16.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.16.3312A Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.16.3313A Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.16.3313E Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.16.49001 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

Location

1199.16.49004 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1199.16.49008 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

1199.16.49005 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Neoplasms

Interventions

nintedanib

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: October 1, 2004
• Primary Completion: September 1, 2009
• Last Updated: December 2, 2014
• Results First Posted: December 2, 2014

Record last verified: 2014-11

Locations

DE (4); FR (7)