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NCT02273388

BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

Completed Phase 1 Results posted Last updated 3 October 2023
What this trial tests

Phase 1 trial testing BI 6727 in Neoplasms in 65 participants. Completed in 6 April 2021.

Timeline
4 November 2005
Primary endpoint
19 January 2009
6 April 2021

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment65
Start date4 November 2005
Primary completion19 January 2009
Estimated completion6 April 2021
Sites2 locations across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) Primary · 21 days (first treatment course).

MTD is defined as: the dose of BI 6727 which is one dose tier below that dose at which two or more out of a maximum of six patients experienced dose-limiting toxicity (DLT). At the maximum tolerated dose, no more than one patient out of six patients may experience DLT, i.e. MTD is defined as the highest dose studied for which the incidence of dose-limiting toxicity is no more than 17% (i.e. 1/6 patients) during the first course. DLT is defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or 4 non haematological toxicity (except emesis or diarrhoea responding

GroupValue95% CI
BI 6727400
Number of Participants With Adverse Events (AEs) Secondary · From first drug administration until last drug administration plus 21 days, up to 835 days.

Number of participants with adverse events. The events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. Grade refers to the severity of adverse event. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.

Grade 1
GroupValue95% CI
12 mg BI 67271
24 mg BI 67271
48 mg BI 67271
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67272
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h0
350 mg BI 67271
400 mg BI 67271
450 mg BI 67270
Grade 2
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67271
75 mg BI 67271
125 mg BI 67273
200 mg BI 67272
300 mg BI 67276
300 mg BI 6727 1h2h2
300 mg BI 6727 2h1h3
350 mg BI 67270
400 mg BI 67271
450 mg BI 67270
Grade 3
GroupValue95% CI
12 mg BI 67271
24 mg BI 67271
48 mg BI 67270
75 mg BI 67270
125 mg BI 67271
200 mg BI 67270
300 mg BI 67274
300 mg BI 6727 1h2h3
300 mg BI 6727 2h1h2
350 mg BI 67272
400 mg BI 67272
450 mg BI 67270
Grade 4
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h1
350 mg BI 67271
400 mg BI 67276
450 mg BI 67272
Grade 5
GroupValue95% CI
12 mg BI 67272
24 mg BI 67271
48 mg BI 67271
75 mg BI 67271
125 mg BI 67270
200 mg BI 67271
300 mg BI 67273
300 mg BI 6727 1h2h2
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67270
450 mg BI 67270
Number of Participants With Clinically Relevant Abnormalities Secondary · From baseline to the last value on treatment, up to 814 days.

Number of participants with clinically relevant abnormalities, occurring in \>5% of the total number of participants, is reported. Clinically relevant post baseline values with Common Terminology Criteria for Adverse Events (CTCAE) grades: * CTCAE grade ≥4 for White blood cell count (WBC) , Neutrophils (NEUT), NEUABS Lymphocytes (LMPH) if baseline CTCAE grade is not 4 * CTCAE grade ≥3 for Haemoglobin (HGB), Platelets count (PLTCT), Alkaline phosphatase (ALKP), serum glutamic-oxaloacetic-transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), total bilirubin (TBILI), if baseline CTCA

Haematocrit
GroupValue95% CI
12 mg BI 67271
24 mg BI 67272
48 mg BI 67271
75 mg BI 67271
125 mg BI 67272
200 mg BI 67273
300 mg BI 672710
300 mg BI 6727 1h2h4
300 mg BI 6727 2h1h2
350 mg BI 67274
400 mg BI 67277
450 mg BI 67271
Haemoglobin
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67271
300 mg BI 67272
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h1
350 mg BI 67272
400 mg BI 67273
450 mg BI 67270
Mean corpuscular volume (MCV)
GroupValue95% CI
12 mg BI 67270
24 mg BI 67271
48 mg BI 67270
75 mg BI 67271
125 mg BI 67270
200 mg BI 67271
300 mg BI 67272
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h1
350 mg BI 67270
400 mg BI 67272
450 mg BI 67271
Platelets
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67272
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h2
350 mg BI 67271
400 mg BI 67274
450 mg BI 67272
Red blood cell count (RBC)
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67271
75 mg BI 67271
125 mg BI 67272
200 mg BI 67272
300 mg BI 67277
300 mg BI 6727 1h2h4
300 mg BI 6727 2h1h1
350 mg BI 67273
400 mg BI 67274
450 mg BI 67272
White blood cell count (WBC)
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67271
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h1
350 mg BI 67272
400 mg BI 67272
450 mg BI 67270
Neutrophils
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67272
300 mg BI 6727 1h2h2
300 mg BI 6727 2h1h1
350 mg BI 67272
400 mg BI 67276
450 mg BI 67272
Sodium
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67271
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67271
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h0
350 mg BI 67271
400 mg BI 67272
450 mg BI 67270
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score Secondary · At baseline and at end of treatment (up to 814 days).

ECOG score: The scale of ECOG score is defined as a six point categorical scale as described ranging from 0 (asymptomatic) to 5 (death). ECOG score change from baseline to end of treatment is calculated, and defined as = ECOG score at end of treatment - ECOG score at baseline. Scale of ECOG score change: The ECOG score changes from baseline score are categorized on a three point categorical scale: Improved, unchanged, and deteriorated. Improvement or deterioration of performance status required a decrease or an increase from baseline, respectively, of at least one point on the ECOG scale. T

Improved
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67270
450 mg BI 67270
Unchanged
GroupValue95% CI
12 mg BI 67271
24 mg BI 67272
48 mg BI 67271
75 mg BI 67271
125 mg BI 67271
200 mg BI 67272
300 mg BI 67277
300 mg BI 6727 1h2h2
300 mg BI 6727 2h1h2
350 mg BI 67273
400 mg BI 67272
450 mg BI 67270
Deteriorated
GroupValue95% CI
12 mg BI 67272
24 mg BI 67271
48 mg BI 67272
75 mg BI 67271
125 mg BI 67273
200 mg BI 67271
300 mg BI 67277
300 mg BI 6727 1h2h5
300 mg BI 6727 2h1h4
350 mg BI 67272
400 mg BI 67278
450 mg BI 67272
Unknown
GroupValue95% CI
12 mg BI 67271
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67271
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67270
450 mg BI 67270
Electrocardiogram (ECG) - QTcF Change From Baseline Secondary · At baseline and 5 minutes before infusion end, 1 hour after end of infusion and at 4 and 12 hours after start of infusion, at course 1.

Electrocardiogram (ECG) - QTcF change from baseline. QTcF intervals form the ECGs were analysed for changes during and after intravenous infusion of BI 300 mg dose over 1 hours and over 2 hours. For baseline ECG, the combined baseline, defined as the mean of the 2 triplicates at the time-point closest to but prior to the start of the infusion of both treatment courses, i.e. a common baseline is used for both treatment courses, was used. Mean is adjusted mean. Abbreviations: QTcF: QT interval, corrected for heart rate according to Fridericia's formula (seconds) = measured QT / (cube root of p

CfB to 5 minutes before infusion end
GroupValue95% CI
300 mg BI 6727 1h17.7913.68 – 21.90
300 mg BI 6727 2h13.238.83 – 17.64
CfB to 1 hours after infusion end
GroupValue95% CI
300 mg BI 6727 1h13.999.88 – 18.10
300 mg BI 6727 2h6.842.44 – 11.25
CfB to 4 hours after infusion start
GroupValue95% CI
300 mg BI 6727 1h10.656.54 – 14.76
300 mg BI 6727 2h7.082.67 – 11.48
CfB to 24 hours after infusion start
GroupValue95% CI
300 mg BI 6727 1h4.330.22 – 8.44
300 mg BI 6727 2h-4.33-8.73 – 0.07
Vital Signs - Blood Pressure Secondary · At baseline.

Systolic blood pressure and diastolic blood pressure are reported.

Systolic blood pressure
GroupValue95% CI
12 mg BI 6727126110 – 155
24 mg BI 6727124107 – 148
48 mg BI 6727124110 – 134
75 mg BI 6727112100 – 124
125 mg BI 672711099 – 131
200 mg BI 6727130116 – 164
300 mg BI 6727125102 – 172
300 mg BI 6727 1h2h129100 – 146
300 mg BI 6727 2h1h148120 – 165
350 mg BI 6727135110 – 149
400 mg BI 672714488 – 178
450 mg BI 6727129128 – 130
Diastolic blood pressure
GroupValue95% CI
12 mg BI 67277460 – 80
24 mg BI 67278068 – 90
48 mg BI 67277878 – 85
75 mg BI 67277570 – 80
125 mg BI 672771.558 – 80
200 mg BI 67277672 – 90
300 mg BI 67278069 – 98
300 mg BI 6727 1h2h78.567 – 89
300 mg BI 6727 2h1h86.560 – 100
350 mg BI 67278270 – 90
400 mg BI 672781.545 – 100
450 mg BI 67277570 – 80
Vital Signs - Pulse Rate Secondary · At baseline.

Pulse rate is reported.

GroupValue95% CI
12 mg BI 67278876 – 92
24 mg BI 67278072 – 98
48 mg BI 67278873 – 92
75 mg BI 67279288 – 96
125 mg BI 67279184 – 99
200 mg BI 67278866 – 96
300 mg BI 67277864 – 120
300 mg BI 6727 1h2h8459 – 97
300 mg BI 6727 2h1h7558 – 104
350 mg BI 67277667 – 100
400 mg BI 67278262 – 114
450 mg BI 67277674 – 78
Number of Participants With Unconfirmed Best Overall Response Secondary · Up to 814 days.

For solid tumours, evaluation of tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) definition. The overall response of target and non-target lesions together with or without the appearance of new lesions as reported by the investigator was assessed on a four point categorical scale as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the RECIST criteria. In order to best handle measurements that were non-evaluable (NEV) a modified version of the RECIST criteria was used. If a RECIST o

Complete response
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67270
450 mg BI 67270
Partial Response
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h1
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67271
450 mg BI 67271
Stable disease
GroupValue95% CI
12 mg BI 67271
24 mg BI 67272
48 mg BI 67271
75 mg BI 67270
125 mg BI 67271
200 mg BI 67271
300 mg BI 67277
300 mg BI 6727 1h2h4
300 mg BI 6727 2h1h2
350 mg BI 67271
400 mg BI 67275
450 mg BI 67271
Non-evaluable, clinically non-progressive disease (NEVCNPD)
GroupValue95% CI
12 mg BI 67270
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67271
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67271
450 mg BI 67270
Progressive Disease (PD) or NEVCPD
GroupValue95% CI
12 mg BI 67272
24 mg BI 67271
48 mg BI 67272
75 mg BI 67272
125 mg BI 67272
200 mg BI 67272
300 mg BI 67278
300 mg BI 6727 1h2h3
300 mg BI 6727 2h1h4
350 mg BI 67274
400 mg BI 67273
450 mg BI 67270
Unknown
GroupValue95% CI
12 mg BI 67271
24 mg BI 67270
48 mg BI 67270
75 mg BI 67270
125 mg BI 67270
200 mg BI 67270
300 mg BI 67270
300 mg BI 6727 1h2h0
300 mg BI 6727 2h1h0
350 mg BI 67270
400 mg BI 67270
450 mg BI 67270
Number of Participants With Progression Secondary · Up to 814 days.

Number of participants with progression of disease. Progressive disease is defined according to the Response Evaluation Criteria in Solid Tumours (RECIST) as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter.

GroupValue95% CI
12 mg BI 67273
24 mg BI 67273
48 mg BI 67273
75 mg BI 67272
125 mg BI 67274
200 mg BI 67273
300 mg BI 672715
300 mg BI 6727 1h2h7
300 mg BI 6727 2h1h6
350 mg BI 67275
400 mg BI 672710
450 mg BI 67271
Maximum Concentration of BI 6727 in Plasma (Cmax) Secondary · At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Maximum concentration of BI 6727 in plasma (Cmax). Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h: For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 4, 8, 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727). For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 3, 4 and 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).

GroupValue95% CI
12 mg BI 672718.8± 14.3
24 mg BI 672750.7± 12.4
48 mg BI 672791.1± 17.6
75 mg BI 6727169.0± 11.7
125 mg BI 6727234.0± 30.9
200 mg BI 6727470.0± 57.6
300 mg BI 6727758± 28.8
300 mg BI 6727 1h2h519.0± 60.3
300 mg BI 6727 2h1h246.0± 68.8
350 mg BI 6727724.0± 23.6
400 mg BI 67271020.0± 20.9
450 mg BI 67271450.0± 8.81
Time From Dosing to Maximum Concentration (Tmax) Secondary · At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Time from dosing to maximum concentration (tmax). Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h: For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 4, 8, 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727). For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 3, 4 and 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).

GroupValue95% CI
12 mg BI 67270.6670.500 – 0.750
24 mg BI 67270.7500.750 – 1.25
48 mg BI 67270.5000.250 – 0.533
75 mg BI 67270.8840.767 – 1.00
125 mg BI 67270.5330.500 – 0.733
200 mg BI 67271.000.500 – 1.03
300 mg BI 67270.7500.500 – 1.00
300 mg BI 6727 1h2h1.000.967 – 1.01
300 mg BI 6727 2h1h2.001.98 – 2.00
350 mg BI 67270.7500.750 – 0.867
400 mg BI 67270.7500.250 – 1.00
450 mg BI 67270.5170.250 – 0.783
Area Under the Concentration-time Curve of BI 6727 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) Secondary · 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 and 504 hours after start of infusion. (*Immediately prior to end of infusion of BI 6727).

Area under the concentration-time curve of BI 6727 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

GroupValue95% CI
12 mg BI 6727149± 31.6
24 mg BI 6727380± 38.9
48 mg BI 6727778± 25.1
75 mg BI 67271270± 7.64
125 mg BI 67272140± 27.9
200 mg BI 67275670± 36.7
300 mg BI 67276540± 32.6
350 mg BI 672710000± 57.6
400 mg BI 67277510± 19.3
450 mg BI 672710900± 14.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until last drug administration plus 21 days, up to 835 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

12 mg BI 6727
Serious: 3/4 (75%)
Deaths: 3/4
24 mg BI 6727
Serious: 2/3 (67%)
Deaths: 2/3
48 mg BI 6727
Serious: 2/3 (67%)
Deaths: 1/3
75 mg BI 6727
Serious: 1/2 (50%)
Deaths: 1/2
125 mg BI 6727
Serious: 0/4 (0%)
Deaths: 1/4
200 mg BI 6727
Serious: 2/3 (67%)
Deaths: 1/3
300 mg BI 6727
Serious: 9/15 (60%)
Deaths: 6/15
300 mg BI 6727 1h2h
Serious: 3/8 (38%)
Deaths: 4/8
300 mg BI 6727 2h1h
Serious: 1/6 (17%)
Deaths: 2/6
350 mg BI 6727
Serious: 3/5 (60%)
Deaths: 0/5
400 mg BI 6727
Serious: 5/10 (50%)
Deaths: 2/10
450 mg BI 6727
Serious: 2/2 (100%)
Deaths: 0/2

Serious adverse events (42 terms)

ReactionSystem12 mg BI 672724 mg BI 672748 mg BI 672775 mg BI 6727125 mg BI 6727200 mg BI 6727300 mg BI 6727300 mg BI 6727 1h2h300 mg BI 6727 2h1h350 mg BI 6727400 mg BI 6727450 mg BI 6727
AnaemiaBlood and lymphatic system disorders
Febrile neutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
General physical health deteriorationGeneral disorders
LeukopeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
Angina pectorisCardiac disorders
Vision blurredEye disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
Mesenteric artery stenosisGastrointestinal disorders
NauseaGastrointestinal disorders
Thrombosis mesenteric vesselGastrointestinal disorders
VolvulusGastrointestinal disorders
VomitingGastrointestinal disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
AppendicitisInfections and infestations
Fusobacterium infectionInfections and infestations
InfectionInfections and infestations
Lung infectionInfections and infestations
PneumoniaInfections and infestations
Septic shockInfections and infestations
Skin infectionInfections and infestations
Other adverse events (126 terms — click to expand)

ReactionSystem12 mg BI 672724 mg BI 672748 mg BI 672775 mg BI 6727125 mg BI 6727200 mg BI 6727300 mg BI 6727300 mg BI 6727 1h2h300 mg BI 6727 2h1h350 mg BI 6727400 mg BI 6727450 mg BI 6727
AnaemiaBlood and lymphatic system disorders
FatigueGeneral disorders
NeutropeniaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
StomatitisGastrointestinal disorders
PyrexiaGeneral disorders
Decreased appetiteMetabolism and nutrition disorders
AnxietyPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
ThrombocytopeniaBlood and lymphatic system disorders
General physical health deteriorationGeneral disorders
Oedema peripheralGeneral disorders
Hepatic painHepatobiliary disorders
GastroenteritisInfections and infestations
Weight decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
Neck painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
DysuriaRenal and urinary disorders
Night sweatsSkin and subcutaneous tissue disorders
HypertensionVascular disorders
Febrile neutropeniaBlood and lymphatic system disorders
Angina pectorisCardiac disorders
Cardiac tamponadeCardiac disorders
Pericardial effusionCardiac disorders
VertigoEar and labyrinth disorders
PhotophobiaEye disorders
Vision blurredEye disorders
Abdominal discomfortGastrointestinal disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
AscitesGastrointestinal disorders
Dry mouthGastrointestinal disorders
DyspepsiaGastrointestinal disorders

Most-reported serious reactions: Anaemia, Febrile neutropenia, Thrombocytopenia, General physical health deterioration, Leukopenia, Neutropenia, Angina pectoris, Vision blurred.

Data from ClinicalTrials.gov NCT02273388 adverse events section.

Sponsor's own description

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
    Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
  2. The two sides of chromosomal instability: drivers and brakes in cancer.
    Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
  3. Evolving Therapeutic Strategies to Exploit Chromosome Instability in Cancer.
    Thompson LL, Jeusset LM, Lepage CC, McManus KJ. · · 2017 · cited 55× · PMID 29104272 · DOI 10.3390/cancers9110151
  4. Second-Generation Antimitotics in Cancer Clinical Trials.
    Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
  5. Seize the engine: Emerging cell cycle targets in breast cancer.
    Fuentes-Antrás J, Bedard PL, Cescon DW. · · 2024 · cited 21× · PMID 38264947 · DOI 10.1002/ctm2.1544
  6. Caspase-8 and Tyrosine Kinases: A Dangerous Liaison in Cancer.
    Contadini C, Ferri A, Cirotti C, Stupack D, et al · · 2023 · cited 11× · PMID 37444381 · DOI 10.3390/cancers15133271
  7. Polo-like kinase 1 inhibition in NSCLC: mechanism of action and emerging predictive biomarkers.
    Stratmann JA, Sebastian M. · · 2019 · cited 9× · PMID 31308774 · DOI 10.2147/lctt.s177618

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