Carcinoma, Non-Small-Cell LungPhase 2NCT02182050
Efficacy and Safety of Oral Treatment With BIBF 1120 ES in Advanced Non-small-cell Lung Cancer
A Phase 2 study testing BIBF 1120 ES low dose and BIBF 1120 ES high dose in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- BIBF 1120 ES low dose and BIBF 1120 ES high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Radiotherapy within the last 4 weeks prior start of treatment with the trial drug and radiotherapy to an area of measurable disease.
- Hypersensitivity to BIBF 1120 ES or the excipients of the trial drug.
- Male or female patients who are sexually active and unwilling to use a medically acceptable method of contraception prior to study entry and for the duration of study participation.
- Pregnancy or breast feeding.
- Known or suspected active alcohol or drug abuse.
- Patients unable to comply with the protocol.
About this study
Official title: A Double-blind, Randomised Phase II Study to Determine Efficacy and Safety of Oral Treatment With BIBF 1120 ES 250 mg Twice Daily Versus 150 mg Twice Daily in Patients Suffering From Advanced Non-small-cell Lung Cancer
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
- Being tested
- BIBF 1120 ES low dose, BIBF 1120 ES high dose, Placebo to BIBF 1120 ES
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 ES low doseDrug
BIBF 1120 ES high doseDrug
Placebo to BIBF 1120 ESDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 ES low dose | Experimental | Not described Receives: Drug: BIBF 1120 ES low dose |
| BIBF 1120 ES high dose | Experimental | Not described Receives: Drug: BIBF 1120 ES high dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo to BIBF 1120 ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour response according to response evaluation criteria in solid tumours (RECIST)
Measured: baseline, every 6 weeks for an expected mean observation duration of 9 months
Time to tumour progression
Measured: baseline, every 6 weeks for an expected mean observation duration of 9 months
Secondary outcomes (9)
Overall survival
Measured: mean observation duration of 9 months
European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) score
Measured: mean observation duration of 9 months
EORTC QLC lung cancer module (QLQ-LC13) score
Measured: mean observation duration of 9 months
Incidence and intensity of adverse events, graded by Common Terminology Criteria (CTCAE) 3.0
Measured: mean observation duration of 9 months
Changes in safety laboratory parameters
Measured: mean observation duration of 9 months
Eastern Cooperative Oncology Group (ECOG) performance score
Measured: mean observation duration of 9 months
Changes in vital signs (body temperature, blood pressure, pulse rate, respiratory rate)
Measured: mean observation duration of 9 months
Maximum plasma concentration (Cmax)
Measured: pre-dose, 1, 2, and 3 hours after administration
Area under the curve (AUC)
Measured: pre-dose, 1, 2, and 3 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2005
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182050
- Sponsor's protocol ID
- 1199.10
- Status last verified
- Dec 2017
- First submitted
- 2 Jul 2014
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised Phase II Study to Determine Efficacy and Safety of Oral Treatment With BIBF 1120 ES 250 mg Twice Daily Versus 150 mg Twice Daily in Patients Suffering From Advanced Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02182050
- Acronym / sponsor ID
- 1199.10
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jan 2007 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Tumour response according to response evaluation criteria in solid tumours (RECIST)
Time frame: baseline, every 6 weeks for an expected mean observation duration of 9 months
Time to tumour progression
Time frame: baseline, every 6 weeks for an expected mean observation duration of 9 months
9 secondary outcomes
Overall survival
Time frame: mean observation duration of 9 months
European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) score
Time frame: mean observation duration of 9 months
EORTC QLC lung cancer module (QLQ-LC13) score
Time frame: mean observation duration of 9 months
Incidence and intensity of adverse events, graded by Common Terminology Criteria (CTCAE) 3.0
Time frame: mean observation duration of 9 months
Changes in safety laboratory parameters
Time frame: mean observation duration of 9 months
Eastern Cooperative Oncology Group (ECOG) performance score
Time frame: mean observation duration of 9 months
Changes in vital signs (body temperature, blood pressure, pulse rate, respiratory rate)
Time frame: mean observation duration of 9 months
Maximum plasma concentration (Cmax)
Time frame: pre-dose, 1, 2, and 3 hours after administration
Area under the curve (AUC)
Time frame: pre-dose, 1, 2, and 3 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBF 1120 ES low dose and BIBF 1120 ES high dose in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour response according to response evaluation criteria in solid tumours (RECIST) (time frame: baseline, every 6 weeks for an expected mean observation duration of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.