Carcinoma, Non-Small-Cell LungPhase 2NCT00824408
Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC
A Phase 2 study testing pemetrexed and BI 6727 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 12 sites in 2 countries.
Trial summary
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy. 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?
- pemetrexed and BI 6727
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Mar 2009to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologic confirmed diagnosis of NSCLC
- Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
- Patients who are eligible for pemetrexed as second line chemotherapy
- Measurable disease by one or more techniques (CT, MRI) according to RECIST
- Patients aged 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 guidelines and local legislation
Who cannot join
- Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
- Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
- Any persisting toxicities which are deemed to be clinically significant from the previous therapy
- Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
- Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
- Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
Show all 23Show fewer
- Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
- Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
- Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
- Patients who have received prior therapy with pemetrexed
- Absolute neutrophil count (ANC) less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Hemoglobin <90g/L
- Total bilirubin >26µmol/L
- Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
- Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min
- Clinically relevant QTc prolongation
- 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
- Any known hypersensitivity to the trial drugs or their excipients
- Patients with NSCLC of confirmed Squamous histology
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada11 sites
1230.5.00104 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1230.5.00105 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1230.5.00114 Boehringer Ingelheim Investigational Site
Kelowna, British Columbia
1230.5.00119 Boehringer Ingelheim Investigational Site
Kitchener, Ontario
1230.5.00102 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1230.5.00106 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1230.5.00116 Boehringer Ingelheim Investigational Site
Oshawa, Ontario
1230.5.00108 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1230.5.00109 Boehringer Ingelheim Investigational Site
Surrey, British Columbia
1230.5.00110 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1230.5.00107 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
The Bahamas1 site
1230.5.00118 Boehringer Ingelheim Investigational Site
Nassau
About this study
Official title: A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.
The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- pemetrexed, BI 6727
- 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.
pemetrexedDrug
500 mg/m^2 i.v. on day 1 of 21 day cycle
pemetrexedDrug
500 mg/m^2 i.v. on day 1 of 21 day cycle
BI 6727Drug
BI 6727 i.v. on day 1 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| BI 6727 +pemetrexed | Experimental | BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle Receives: Drug: pemetrexed; Drug: BI 6727 |
| pemetrexed | Active comparator | 500 mg/m^2 i.v. on day 1 of a 21 day cycle Receives: Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.
The number of participants analysed displays the number of patients with an event (progression).
Measured: From randomization until disease progression or death
Secondary outcomes (12)
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
Measured: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
Overall survival (OS) was defined as the duration of time from randomization to time of death.
Measured: From randomization until time of death
Duration of Overall Response
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
Measured: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:
- treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
- treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
- CTCAE Grade 4 thrombocytopenia.
Measured: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
Frequency of patients with possible clinically significant abnormalities
Measured: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
Cmax - maximum measured concentration of volasertib in plasma.
Measured: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
CL - total clearance of volasertib in plasma after IV administration
Measured: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
Vss - apparent volume of distribution at steady state following IV administration of volasertib
Measured: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
Cmax - maximum measured concentration of pemetrexed in plasma
Measured: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
CL - total clearance of pemetrexed in plasma after IV administration
Measured: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
Measured: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824408
- Sponsor's protocol ID
- 1230.5
- Status last verified
- Jul 2016
- First submitted
- 15 Jan 2009
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ellis PM, Leighl NB, Hirsh V, Reaume MN, Blais N, Wierzbicki R, Sadrolhefazi B, Gu Y, Liu D, Pilz K, Chu Q. A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):457-65. doi: 10.1016/j.cllc.2015.05.010. Epub 2015 Jun 2.
PubMed 26100229
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00824408
- Acronym / sponsor ID
- 1230.5
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 20 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.
The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 6727 +pemetrexed | Experimental | Drug: pemetrexed, Drug: BI 6727BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle |
| pemetrexed | Active comparator | Drug: pemetrexed500 mg/m^2 i.v. on day 1 of a 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologic or cytologic confirmed diagnosis of NSCLC
- Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
- Patients who are eligible for pemetrexed as second line chemotherapy
- Measurable disease by one or more techniques (CT, MRI) according to RECIST
- Patients aged 18 years or older
Key exclusion criteria (23 listed)
- Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
- Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
- Any persisting toxicities which are deemed to be clinically significant from the previous therapy
- Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
- 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 |
|---|---|---|
| pemetrexed500 mg/m^2 i.v. on day 1 of 21 day cycle | Drug | BI 6727 +pemetrexed |
| pemetrexed500 mg/m^2 i.v. on day 1 of 21 day cycle | Drug | pemetrexed |
| BI 6727BI 6727 i.v. on day 1 of a 21 day cycle | Drug | BI 6727 +pemetrexed |
Primary outcome
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
Time frame: From randomization until disease progression or death
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day. The number of participants analysed displays the number of patients with an event (progression).
12 secondary outcomes
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Time frame: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
Time frame: From randomization until time of death
Duration of Overall Response
Time frame: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
Time frame: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
Time frame: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
Time frame: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
Time frame: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
Time frame: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
Time frame: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
Time frame: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
Time frame: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
Time frame: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26100229Ellis PM, Leighl NB, Hirsh V, Reaume MN, Blais N, Wierzbicki R, Sadrolhefazi B, Gu Y, Liu D, Pilz K, Chu Q. A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):457-65. doi: 10.1016/j.cllc.2015.05.010. Epub 2015 Jun 2.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed and BI 6727 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 12 sites in 2 countries.
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 8 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, The Bahamas. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Yes. Results are posted in the registry (first posted 20 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First. (time frame: From randomization until disease progression or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824408, which also lists 1 linked publication.
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 20 Sep 2016.