Carcinoma, Non-Small-Cell LungPhase 1NCT02182232
A Dose Escalation Study of BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer
A Phase 1 study testing BIBF 1120, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
Trial summary
The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment 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, Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to May 2007
- 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
- Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
- Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
- Age 18 years or older
- Life expectancy of at least three (3) months
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
- Written informed consent that is consistent with ICH-GCP guidelines
Who cannot join
- Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
- Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
- Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
- Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
- Cavitary or necrotic tumors
- Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
Show all 23Show fewer
- Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
- Radiotherapy within 4 weeks preceding Day 0
- Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
- Gastrointestinal abnormalities that would interfere with intake or absorption 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, ≥NYHA Grade 2 congestive heart failure)
- History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months
- Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
- Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose daily aspirin <325 mg)
- Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients including Cremophor® (polyoxyethylated castor oil)
- Absolute neutrophil count (ANC) ≤1,500/μl, platelet count ≤100,000/μl, or hemoglobin <9 gm/dL
- Total bilirubin >1.5 mg/dL (26 μmol/L, SI Unit equivalent), alanine amino transferase (ALT) and/or aspartate amino transferase (AST) ≥1.5 X ULN,
- Serum creatinine >1.5 mg/dL (>132 μmol/L, SI Unit equivalent)
- 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 breastfeeding
- 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 Dose Escalation Study of Continuous Oral Treatment With BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer
The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BIBF 1120, Paclitaxel, Carboplatin
- 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
PaclitaxelDrug
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 with paclitaxel and carboplatin | Experimental | Not described Receives: Drug: BIBF 1120; Drug: Paclitaxel; Drug: Carboplatin |
| BIBF 1120 monotherapy | Experimental | Not described Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120
Measured: up to day 126
Maximum tolerated dose (MTD) of BIBF 1120 in combination with carboplatin and paclitaxel
Measured: up to day 21
Secondary outcomes (20)
Pre-dose plasma concentration (Cpre)
Measured: up to day 42
Objective tumor response according to response evaluation criteria in solid tumors (RECIST)
Measured: up to 12 months
Time from best response to onset of tumor progression
Measured: Up to 12 months
Time from start of treatment to time of documented tumor progression
Measured: Up to 12 months
area under the curve (AUC) from 0 to 12 hours (AUC0-12)
Measured: up to day 42
AUC from 0 to the last quantifiable drug concentration (AUC0-tz)
Measured: up to day 42
Maximum plasma concentration (Cmax)
Measured: up to day 42
Time to maximum plasma concentration (tmax)
Measured: up to day 42
Rate constant (λz) for BIBF 1120
Measured: up to day 42
AUC from 0 to 24 hours (AUC0-24) for paclitaxel
Measured: up to day 42
AUC from 0 extrapolated to 48 hours (AUC0-48) for paclitaxel
Measured: up to day 42
AUC from 0 extrapolated to infinity (AUC0-∞)
Measured: up to day 42
Percentage of AUC0-∞ that is obtained by extrapolation (% AUCtz-∞)
Measured: up to day 42
Terminal half-life (t1/2)
Measured: up to day 42
Mean residence time after intravenous administration (MRTiv) for paclitaxel and carboplatin
Measured: up to day 42
Total Clearance (CL/F)
Measured: up to day 42
Volume of distribution during the terminal phase (Vz)
Measured: up to day 42
AUC from 0 to 24 hours (AUC0-24) for carboplatin
Measured: Day 1 and 22 in the treatment time
Plasma concentration 21 hours after start of infusion (C21) for carboplatin
Measured: up to day 42
Plasma concentration 24 hours after start of infusion (C24) for paclitaxel
Measured: up to day 42
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 startJun 2005
- Primary completionMay 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT02182232
- Sponsor's protocol ID
- 1199.5
- 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 Dose Escalation Study of Continuous Oral Treatment With BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02182232
- Acronym / sponsor ID
- 1199.5
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- May 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 primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 with paclitaxel and carboplatin | Experimental | Drug: BIBF 1120, Drug: Paclitaxel, Drug: Carboplatin |
| BIBF 1120 monotherapy | Experimental | Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
- Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
- Age 18 years or older
- Life expectancy of at least three (3) months
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Key exclusion criteria (23 listed)
- Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
- Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
- Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
- Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
- Cavitary or necrotic tumors
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 with paclitaxel and carboplatin |
| Paclitaxel | Drug | BIBF 1120 with paclitaxel and carboplatin |
| Carboplatin | Drug | BIBF 1120 monotherapy, BIBF 1120 with paclitaxel and carboplatin |
Primary outcome
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120
Time frame: up to day 126
Maximum tolerated dose (MTD) of BIBF 1120 in combination with carboplatin and paclitaxel
Time frame: up to day 21
20 secondary outcomes
Pre-dose plasma concentration (Cpre)
Time frame: up to day 42
Objective tumor response according to response evaluation criteria in solid tumors (RECIST)
Time frame: up to 12 months
Time from best response to onset of tumor progression
Time frame: Up to 12 months
Time from start of treatment to time of documented tumor progression
Time frame: Up to 12 months
area under the curve (AUC) from 0 to 12 hours (AUC0-12)
Time frame: up to day 42
AUC from 0 to the last quantifiable drug concentration (AUC0-tz)
Time frame: up to day 42
Maximum plasma concentration (Cmax)
Time frame: up to day 42
Time to maximum plasma concentration (tmax)
Time frame: up to day 42
Rate constant (λz) for BIBF 1120
Time frame: up to day 42
AUC from 0 to 24 hours (AUC0-24) for paclitaxel
Time frame: up to day 42
AUC from 0 extrapolated to 48 hours (AUC0-48) for paclitaxel
Time frame: up to day 42
AUC from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to day 42
Percentage of AUC0-∞ that is obtained by extrapolation (% AUCtz-∞)
Time frame: up to day 42
Terminal half-life (t1/2)
Time frame: up to day 42
Mean residence time after intravenous administration (MRTiv) for paclitaxel and carboplatin
Time frame: up to day 42
Total Clearance (CL/F)
Time frame: up to day 42
Volume of distribution during the terminal phase (Vz)
Time frame: up to day 42
AUC from 0 to 24 hours (AUC0-24) for carboplatin
Time frame: Day 1 and 22 in the treatment time
Plasma concentration 21 hours after start of infusion (C21) for carboplatin
Time frame: up to day 42
Plasma concentration 24 hours after start of infusion (C24) for paclitaxel
Time frame: up to day 42
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.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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, Paclitaxel and Carboplatin 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 6 inclusion and 23 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?
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120 (time frame: up to day 126). 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.