Efficacy and Safety of Oral Treatment With BIBF 1120 ES in Advanced Non-small-cell Lung Cancer

NCT02182050 | Completed Phase 2

• 1 other identifier: 1199.10
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120 twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety data for the two different dosages were collected and analysed.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Tumour response according to response evaluation criteria in solid tumours (RECIST)

  baseline, every 6 weeks for an expected mean observation duration of 9 months

• Time to tumour progression

  baseline, every 6 weeks for an expected mean observation duration of 9 months

Secondary Outcomes (9)

• Overall survival

  mean observation duration of 9 months

• European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) score

  mean observation duration of 9 months

• EORTC QLC lung cancer module (QLQ-LC13) score

  mean observation duration of 9 months

• Incidence and intensity of adverse events, graded by Common Terminology Criteria (CTCAE) 3.0

  mean observation duration of 9 months

• Changes in safety laboratory parameters

  mean observation duration of 9 months

Study Arms (3)

BIBF 1120 ES low dose

EXPERIMENTAL

Drug: BIBF 1120 ES low dose

BIBF 1120 ES high dose

EXPERIMENTAL

Drug: BIBF 1120 ES high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo to BIBF 1120 ES

Interventions

BIBF 1120 ES low dose DRUG

BIBF 1120 ES low dose

BIBF 1120 ES high dose DRUG

BIBF 1120 ES high dose

Placebo to BIBF 1120 ES DRUG

Placebo

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 histologically confirmed advanced NSCLC (i.e. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combinations of these) stage IIIB (including pleural effusion) and stage IV.
• Patients with recurrent disease who relapsed after previous treatment with platinum- or non-platinum based chemotherapy.
• Full recovery from all therapy related toxicities from previous chemotherapy/ radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
• Age ≥18 years.
• Life expectancy of at least 3 months.
• ECOG performance score 0, 1 or 2.
• Uni-dimensionally measurable tumour lesions by one or more techniques, i.e. CT, MRI, X-ray.
• Adequate hepatic function: total bilirubin within normal limits; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 1.5x upper limit of normal (ULN) in patients without liver metastasis; For patients with liver metastasis: total bilirubin ≤ 1.5x ULN; ALT and/or AST \< 2.5x ULN.
• Coagulation parameters: international normalised ratio less than 1.3 or prothrombin time (PT) and partial thromboplastin time (PTT) less than 1.5 times institutional ULN.
• Adequate renal function: serum creatinine ≤ 1.5 x upper normal limit.
• Absolute neutrophil count (ANC) ≥ 1500/mL, platelets ≥ 100000/mL, haemoglobin ≥ 9.0 g/dL.
• Written informed consent consistent with ICH-GCP guidelines and local law.

You may not qualify if:

• Active brain metastases stable for \< 4 weeks, symptomatic, or requiring treatment with anti-convulsants and/or steroids or leptomeningeal disease.
• Patients with history of haemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months. Known inherited predisposition to thrombosis.
• Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose daily acetylsalicylic acid \< 325mg).
• Sanguineous pleural effusion due to disease or pericardial effusion suspicious for disease.
• Clinically significant haemoptysis (1 teaspoon or more) within the last 3 months.
• Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
• Radiographic evidence of cavitary or necrotic tumours at screening.
• Major injuries and surgeries. Planned surgical procedures during the trial. Patients with incomplete wound healing within the past 4 weeks.
• Gross haematuria within the last 3 months.
• Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, serious cardiac arrhythmia, congestive heart failure according to New York Heart Association (NYHA) III or IV.
• Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric- or infectious disease 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.
• Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, hematochezia, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes.
• Other malignancy within the past 5 years (other than non-melanomatous skin cancer or cervical carcinoma in situ).
• Treatment with other investigational drugs (elimination half life \< 5 days) within the past 4 weeks before visit 2 or participation in another clinical trial within the past 4 weeks before start of therapy (visit 2) or concomitantly with this trial.
• Treatment with chemo-, immuno-, hormonotherapy or with biologic response modifier within the past four weeks prior to treatment with the trial drug and during the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2005
• Primary Completion: January 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12