A Phase 2 interventional study of pemetrexed and pemetrexed in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 143 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BI 6727 plus 500 mg/\^m2 pemetrexed i.v. on day 1 of 21 day cycle
Drug: pemetrexed · Drug: BI 6727
500 mg/m\^2 i.v. on day 1 of a 21 day cycle
Drug: pemetrexed
500 mg/m\^2 i.v. on day 1 of 21 day cycle
500 mg/m\^2 i.v. on day 1 of 21 day cycle
BI 6727 i.v. on day 1 of a 21 day cycle
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).
Time frame: From randomization until disease progression or death
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.
Time frame: 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.
Time frame: 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.
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.
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).
Time frame: 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.
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
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
Cmax - maximum measured concentration of volasertib in plasma.
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
CL - total clearance of volasertib in plasma after IV administration
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
Vss - apparent volume of distribution at steady state following IV administration 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
Cmax - maximum measured concentration of pemetrexed in plasma
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
CL - total clearance of pemetrexed in plasma after IV administration
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
Vss - apparent volume of distribution at steady state following IV administration 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
| Milestone | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomized Phase: Volasertib 300 mg | Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomized Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| Started | 6 | 6 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 6 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 4 | 4 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Refused to continue medication | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Other reason not defined above | 0 | 1 | 0 | 0 | 0 |
| Milestone | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomized Phase: Volasertib 300 mg | Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomized Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| Started | 0 | 0 | 37 | 47 | 47 |
| Completed | 0 | 0 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 36 | 46 | 46 |
| Withdrew: Not treated | 0 | 0 | 1 | 1 | 1 |
| Withdrew: Progressive disease | 0 | 0 | 25 | 36 | 34 |
| Withdrew: Adverse event | 0 | 0 | 4 | 5 | 5 |
| Withdrew: Refused to continue medication | 0 | 0 | 2 | 2 | 2 |
| Withdrew: Other reason not defined above | 0 | 0 | 4 | 2 | 4 |
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).
| months | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|
| Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First. | 1.4 (1.2 to 1.9) | 3.3 (1.9 to 5.7) | 5.3 (3.1 to 7.2) |
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.
| percentage of participants | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| Complete response (CR) | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Partial response (PR) | 16.7 | 50.0 | 8.1 | 21.3 | 10.6 |
Overall survival (OS) was defined as the duration of time from randomization to time of death.
| months | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|
| Overall Survival (OS) | 22.9 (3.6 to NA) | 17.1 (9.4 to 28.8) | 17.4 (10.3 to 34.6) |
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.
| weeks | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|
| Duration of Overall Response | 23.0 (12.7 to 47.1) | 19.6 (7.1 to 39.1) | 23.4 (10.5 to 45.9) |
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).
| participants | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| CTCAE Grade 1 | 0 | 0 | 6 | 2 | 6 |
| CTCAE Grade 2 | 0 | 2 | 12 | 18 | 18 |
| CTCAE Grade 3 | 3 | 3 | 8 | 19 | 15 |
| CTCAE Grade 4 | 3 | 1 | 6 | 5 | 5 |
| CTCAE Grade 5 | 0 | 0 | 3 | 2 | 0 |
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.
| participants | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 |
|---|---|---|
| Occurence of DLT | 1 | 1 |
Frequency of patients with possible clinically significant abnormalities
| participants | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| Haemoglobin - Low | 1 | 2 | 16 | 21 | 14 |
| White blood cell ct. - Low | 4 | 2 | 15 | 25 | 12 |
| White blood cell ct. - High | 0 | 0 | 1 | 0 | 1 |
| Platelets - Low | 0 | 1 | 8 | 3 | 2 |
| Platelets - High | 0 | 1 | 3 | 0 | 3 |
| Neutrophils - Low | 4 | 2 | 13 | 23 | 12 |
| Lymphocytes - Low | 4 | 4 | 16 | 22 | 22 |
| AST/GOT, SGOT - High | 0 | 1 | 0 | 6 | 3 |
| ALT/GPT, SGPT - High | 0 | 1 | 0 | 10 | 6 |
| Alkaline phosphatase - High | 0 | 0 | 0 | 0 | 5 |
| Creatinine - High | 0 | 0 | 0 | 3 | 0 |
| Bilirubin, total - High | 1 | 0 | 1 | 1 | 1 |
Cmax - maximum measured concentration of volasertib in plasma.
| ng/mL | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg |
|---|---|---|---|
| Cmax of Volasertib | 554 ± 35.9 | 635 ± 51.8 | 565 ± 39.0 |
CL - total clearance of volasertib in plasma after IV administration
| mL/min | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg |
|---|---|---|---|
| Total Clearance (CL) of Volasertib | 782 ± 24.8 | 882 ± 30.4 | 867 ± 31.6 |
Vss - apparent volume of distribution at steady state following IV administration of volasertib
| Litres | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg |
|---|---|---|---|
| Vss of Volasertib | 6730 ± 42.1 | 6750 ± 39.7 | 6230 ± 34.5 |
Cmax - maximum measured concentration of pemetrexed in plasma
| ng/mL | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 |
|---|---|---|
| Cmax of Pemetrexed | 131000 ± 24.7 | 115000 ± 32.1 |
CL - total clearance of pemetrexed in plasma after IV administration
| mL/min | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 |
|---|---|---|
| CL of Pemetrexed | 54.4 ± 17.4 | 69.1 ± 30.0 |
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
| Litres | Volasertib 250 mg + Pemetrexed 500 mg/m2 | Volasertib 300 mg + Pemetrexed 500 mg/m2 |
|---|---|---|
| Vss of Pemetrexed | 9.40 ± 20.5 | 13.1 ± 45.8 |
Collected over From first drug infusion until 21 days after last drug infusion, up to 1100 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | — | 2/6 (33.3%) | 6/6 (100%) |
| Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | — | 0/6 (0%) | 6/6 (100%) |
| Randomization Phase: Volasertib 300 mg | — | 8/36 (22.2%) | 35/36 (97.2%) |
| Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | — | 10/46 (21.7%) | 46/46 (100%) |
| Randomization Phase: Pemetrexed 500 mg/m2 | — | 12/46 (26.1%) | 44/46 (95.7%) |
| Event | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/6 | 0/6 | 0/36 | 0/46 | 0/46 |
| Abdominal painGastrointestinal disorders | 1/6 | 0/6 | 0/36 | 0/46 | 1/46 |
| ConstipationGastrointestinal disorders | 1/6 | 0/6 | 0/36 | 0/46 | 0/46 |
| VomitingGastrointestinal disorders | 1/6 | 0/6 | 0/36 | 0/46 | 0/46 |
| Thrombosis in deviceGeneral disorders | 1/6 | 0/6 | 0/36 | 0/46 | 0/46 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/6 | 0/6 | 1/36 | 1/46 | 1/46 |
| PneumoniaInfections and infestations | 0/6 | 0/6 | 0/36 | 0/46 | 4/46 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/6 | 0/6 | 0/36 | 3/46 | 1/46 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 0/36 | 1/46 | 3/46 |
| DiarrhoeaGastrointestinal disorders | 0/6 | 0/6 | 1/36 | 0/46 | 0/46 |
| Event | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 |
|---|---|---|---|---|---|
| FatigueGeneral disorders | 5/6 | 6/6 | 20/36 | 33/46 | 32/46 |
| NauseaGastrointestinal disorders | 4/6 | 4/6 | 5/36 | 22/46 | 25/46 |
| Decreased appetiteMetabolism and nutrition disorders | 3/6 | 4/6 | 3/36 | 20/46 | 19/46 |
| Dry eyeEye disorders | 0/6 | 3/6 | 0/36 | 0/46 | 2/46 |
| Chest painGeneral disorders | 1/6 | 3/6 | 4/36 | 7/46 | 5/46 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/6 | 3/6 | 5/36 | 5/46 | 2/46 |
| DizzinessNervous system disorders | 1/6 | 3/6 | 7/36 | 9/46 | 2/46 |
| ConstipationGastrointestinal disorders | 1/6 | 2/6 | 6/36 | 17/46 | 10/46 |
| NeutropeniaBlood and lymphatic system disorders | 2/6 | 2/6 | 9/36 | 9/46 | 4/46 |
| VertigoEar and labyrinth disorders | 0/6 | 2/6 | 0/36 | 0/46 | 1/46 |
Randomized set, which included all patients randomised in the randomisation phase, whether treated or not
| Age, Continuous(years) | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 | Total |
|---|---|---|---|---|---|---|
| Mean | 66.2 ± 8.30 | 62.3 ± 6.83 | 62.9 ± 8.60 | 63.5 ± 10.26 | 62.5 ± 8.89 | 63.1 ± 9.12 |
| Sex: Female, Male(Participants) | Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Volasertib 300 mg | Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | Randomization Phase: Pemetrexed 500 mg/m2 | Total |
|---|---|---|---|---|---|---|
| Female | 5 | 4 | 16 | 23 | 25 | 73 |
| Male | 1 | 2 | 21 | 24 | 22 | 70 |
The record gives a start of Mar 2009, a primary completion of Sep 2012 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2016, 4 years after primary completion. A results delay was requested in Apr 2014.
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Studies of the drug tested here: BI 6727
Carcinoma, Non-Small-Cell Lung →