Carcinoma, Non-Small-Cell LungPhase 1NCT02182102
Dose Escalation of BIBF 1120 Combined With Pemetrexed in Advanced Non Small Cell Lung Cancer
A Phase 1 study testing BIBF 1120 and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
Trial summary
The primary objective was to determine the safety, tolerability and maximum tolerate dose (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary anti-tumour efficacy information. 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 and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to May 2010
- Phase
- Phase 1
- 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
- Pathologic confirmation of metastatic, unresectable, or locally advanced NSCLC (non-small cell lung cancer)
- Disease progression during or following one prior platinum-based (including prior neoadjuvant or adjuvant therapy) chemotherapy regimen for advanced disease
- Bi-dimensionally measurable disease by one or more techniques (CT (computed tomography), MRI (magnetic resonance imaging), X-ray)
- Age 18 years or older
- Life expectancy of at least three (3) months
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Written informed consent that is consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines
Who cannot join
- Participation in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
- Treatment for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of this trial. All toxicities of the previous therapy must have resolved to baseline prior to Treatment Day 1
- Patient has received more than one prior chemotherapy regimen for advanced disease
- Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
- Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
- Radiotherapy within 4 weeks prior to Treatment Day 1
Show all 26Show fewer
- Prior treatment with agents that target the vascular endothelial growth factor (VEGF) pathways, including monoclonal antibody therapy (such as bevacizumab) or tyrosine kinase inhibitors
- Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded
- Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels, with exception of those tumors which have received prior irradiation and are stable
- Cavitary or necrotic tumors
- Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
- Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
- Gastrointestinal abnormalities that would interfere with intake or absorption (with exception of patients with gastric esophageal reflux disease controlled with proton pump inhibitors) of the study drug, such as a requirement for intravenous alimentation, 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
- Significant cardiovascular disease (i.e., uncontrolled hypertension, myocardial infarction within 6 months, unstable angina, serious cardiac arrhythmia, >2 New York Heart Association (NYHA) Grade 2 congestive heart failure)
- History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months or clinically significant hemoptysis in the past 3 months
- Patients receiving any anti-coagulant therapy (including coumadin, heparin, low molecular weight heparin, and aspirin
- Patient has received prior therapy with pemetrexed
- Absolute neutrophil count (ANC) ≤1,500/μl, platelet count ≤100,000/μl, or hemoglobin <9 gm/dL
- Total bilirubin >1.5 mg/dL (26 μmole/L, SI-Unit equivalent), alanine amino transferase (ALT) and/or aspartate amino transferase (AST) ≥1.5 X upper limit of normal (ULN)
- Inadequate renal function determined by a serum creatinine level >1.5 X ULN
- Patient is unable or unwilling to interrupt aspirin or other NSAIDS for a 5-day period (8 days period for long lasting agents like piroxicam)
- Persistent hematuria or proteinuria (more than trace)
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- 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 Phase I Open Label Study of Continuous Oral Treatment With BIBF 1120 Together With Pemetrexed in Previously Treated Patients With Non-small Cell Lung Cancer
The primary objective was to determine the safety, tolerability and maximum tolerate dose (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary anti-tumour efficacy information.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BIBF 1120, Pemetrexed
- 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 1120Drug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 + Pemetrexed | Experimental | Not described Receives: Drug: BIBF 1120; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (maximum tolerated dose) of BIBF 1120 in combination with pemetrexed (500 mg/m2).
Measured: up to 126 days
Incidence and intensity of Adverse Events according to the Common Terminology Criteria for Adverse Events (Version 3.0) associated with increasing doses of BIBF 1120.
Measured: up to 126 days
Secondary outcomes (22)
AUC0-24 (Area under the plasma concentration-time curve over the dosing interval τ (24 h) following the first dose of uniform intervals τ)
Measured: before and up to 6 hours after adminstration in cycle 2
AUC0-tz (AUC over the time interval from zero to the time of the last quantifiable drug concentration)
Measured: before and up to 6 hours after adminstration in cycle 2
AUC0-∞ (AUC over the time interval from zero extrapolated to infinity)
Measured: before and up to 6 hours after adminstration in cycle 2
%AUCtz-∞ (the percentage of AUC0-∞ that is obtained by extrapolation)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
Cpre,1 (Pre-dose plasma concentration)
Measured: before first administration of BIBF 1120 on day 2 of cycle 2
C24,1 (Plasma concentration at 24 h following the first dose)
Measured: 24 hours after the first administration of BIBF 1120 in cycle 2
Cmax (Maximum measured plasma concentration following the first dosing intervals τ)
Measured: before and up to 6 hours after adminstration in cycle 2
tmax (Time from dosing to the maximum plasma concentration following the first dosing intervals τ)
Measured: before and up to 6 hours after adminstration in cycle 2
λz (Terminal rate constant in plasma)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
t1/2 (Terminal half-life)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
MRTpo (Mean residence time after oral administration)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
CL/F of BIBF 1120 (Apparent clearance)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration of BIBF 1120 in cycle 2
Vz/F of BIBF 1120 (Apparent volume of distribution during the terminal phase)
Measured: before and 1, 2, 3, 4, 6 hours after first adminstration of BIBF 1120 in cycle 2
% AUCtz-∞ for pemetrexed
Measured: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
C24,1 C48,1 (Plasma concentration at 24 h and 48 h following the first dose of treatment cycle
Measured: 24 and 28 hours after administration in cycle 2
MRTiv for pemetrexed (Mean residence time after i.v. administration)
Measured: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
CL (Clearance) for pemetrexed
Measured: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Vz for pemetrexed (apparent volume of distribution during the terminal phase following an intravascular dose)
Measured: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Vss for pemetrexed (Apparent volume of distribution at steady state)
Measured: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Objective tumor response according to the response evaluation criteria in solid tumors (RECIST)
Measured: up to 56 months
Duration of objective tumor response (time from best response to onset of tumor progression)
Measured: up to 56 months
Time to tumor progression (time from start of treatment to time of documented tumor progression)
Measured: up to 56 months
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 startSep 2005
- Primary completionMay 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT02182102
- Sponsor's protocol ID
- 1199.18
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Study of Continuous Oral Treatment With BIBF 1120 Together With Pemetrexed in Previously Treated Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02182102
- Acronym / sponsor ID
- 1199.18
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2010 (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 primary objective was to determine the safety, tolerability and maximum tolerate dose (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary anti-tumour efficacy information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 + Pemetrexed | Experimental | Drug: BIBF 1120, Drug: Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologic confirmation of metastatic, unresectable, or locally advanced NSCLC (non-small cell lung cancer)
- Disease progression during or following one prior platinum-based (including prior neoadjuvant or adjuvant therapy) chemotherapy regimen for advanced disease
- Bi-dimensionally measurable disease by one or more techniques (CT (computed tomography), MRI (magnetic resonance imaging), X-ray)
- Age 18 years or older
- Life expectancy of at least three (3) months
Key exclusion criteria (26 listed)
- Participation in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
- Treatment for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of this trial. All toxicities of the previous therapy must have resolved to baseline prior to Treatment Day 1
- Patient has received more than one prior chemotherapy regimen for advanced disease
- Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
- Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
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 | Drug | BIBF 1120 + Pemetrexed |
| Pemetrexed | Drug | BIBF 1120 + Pemetrexed |
Primary outcome
MTD (maximum tolerated dose) of BIBF 1120 in combination with pemetrexed (500 mg/m2).
Time frame: up to 126 days
Incidence and intensity of Adverse Events according to the Common Terminology Criteria for Adverse Events (Version 3.0) associated with increasing doses of BIBF 1120.
Time frame: up to 126 days
22 secondary outcomes
AUC0-24 (Area under the plasma concentration-time curve over the dosing interval τ (24 h) following the first dose of uniform intervals τ)
Time frame: before and up to 6 hours after adminstration in cycle 2
AUC0-tz (AUC over the time interval from zero to the time of the last quantifiable drug concentration)
Time frame: before and up to 6 hours after adminstration in cycle 2
AUC0-∞ (AUC over the time interval from zero extrapolated to infinity)
Time frame: before and up to 6 hours after adminstration in cycle 2
%AUCtz-∞ (the percentage of AUC0-∞ that is obtained by extrapolation)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
Cpre,1 (Pre-dose plasma concentration)
Time frame: before first administration of BIBF 1120 on day 2 of cycle 2
C24,1 (Plasma concentration at 24 h following the first dose)
Time frame: 24 hours after the first administration of BIBF 1120 in cycle 2
Cmax (Maximum measured plasma concentration following the first dosing intervals τ)
Time frame: before and up to 6 hours after adminstration in cycle 2
tmax (Time from dosing to the maximum plasma concentration following the first dosing intervals τ)
Time frame: before and up to 6 hours after adminstration in cycle 2
λz (Terminal rate constant in plasma)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
t1/2 (Terminal half-life)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
MRTpo (Mean residence time after oral administration)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2
CL/F of BIBF 1120 (Apparent clearance)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration of BIBF 1120 in cycle 2
Vz/F of BIBF 1120 (Apparent volume of distribution during the terminal phase)
Time frame: before and 1, 2, 3, 4, 6 hours after first adminstration of BIBF 1120 in cycle 2
% AUCtz-∞ for pemetrexed
Time frame: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
C24,1 C48,1 (Plasma concentration at 24 h and 48 h following the first dose of treatment cycle
Time frame: 24 and 28 hours after administration in cycle 2
MRTiv for pemetrexed (Mean residence time after i.v. administration)
Time frame: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
CL (Clearance) for pemetrexed
Time frame: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Vz for pemetrexed (apparent volume of distribution during the terminal phase following an intravascular dose)
Time frame: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Vss for pemetrexed (Apparent volume of distribution at steady state)
Time frame: before and 0.25, 1, 2, 4, 6 hours after administration in cycle 2
Objective tumor response according to the response evaluation criteria in solid tumors (RECIST)
Time frame: up to 56 months
Duration of objective tumor response (time from best response to onset of tumor progression)
Time frame: up to 56 months
Time to tumor progression (time from start of treatment to time of documented tumor progression)
Time frame: up to 56 months
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 18 Jul 2014.
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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 1 study testing BIBF 1120 and Pemetrexed 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 7 inclusion and 26 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 18 Jul 2014. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
MTD (maximum tolerated dose) of BIBF 1120 in combination with pemetrexed (500 mg/m2). (time frame: up to 126 days). 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 18 Jul 2014.