NCT01403974 is a Phase 1 clinical trial of BI 836845 in Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT01403974?

NCT01403974 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT01403974?

Interventions in NCT01403974: BI 836845.

Is NCT01403974 still recruiting?

NCT01403974 is currently completed. Last updated 25 July 2025.

Are results published for NCT01403974?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-25 · How we verify

NCT01403974

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Trial of BI 836845 for Various Solid Cancer

Completed Phase 1 Results posted Last updated 25 July 2025

What this trial tests

Phase 1 trial testing BI 836845 in Neoplasms in 61 participants. Completed in 23 December 2015.

Timeline

19 July 2011

Primary endpoint
8 July 2015

23 December 2015

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	19 July 2011
Primary completion	8 July 2015
Estimated completion	23 December 2015
Sites	3 locations across Taiwan

Drugs / interventions tested

BI 836845 — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

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.

Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase. Primary · During the first course of treatment, up to 21 days

In the absence of MTD, the relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase was reported. The MTD was defined as the highest dose level of BI 836845 at which no more than 1 out of 6 patients experienced a drug related dose limiting toxicity (DLT) during the first course of treatment. Starting dose of 10 milligrams (mg) BI 836845, administered thrice every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 60 mg, 90 mg, 135 mg, 200 mg, 300 mg, 450 mg, 600 mg, 800 mg, 1050 mg, 1400 mg and 1800 mg. The BI 836845 dose which could ac

Group	Value	95% CI
Part 1: BI 836845	1000

Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period Primary · During the first course of treatment, up to 21 days

Number of participants with DLTs occurring during the first treatment course of the dose escalation part. DLT was defined as drug-related adverse events meeting the criteria summarized below: * Common terminology criteria for adverse events (CTCAE) grade 4 neutropenia for ≥ 7 days (d) * Febrile neutropenia with single temperature of \> 38.3°C/ ≥ 38°C more than 1 hour (h) * Documented infection with high neutrophile count * CTCAE grade 4 thrombocytopenia/CTCAE grade 3 thrombocytopenia associated with bleeding requiring transfusion * AST (Aspartate Amino Transferase)/ALT (Alanine Amino Transfer

Group	Value	95% CI
Part 1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	1
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	0

Objective Tumour Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 Secondary · First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Number of patients with the objective response (OR). Objective response was defined as best overall response of complete response (CR) or partial response (PR) (with no confirmation required) based on Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The best overall response was recorded since first administration of the trial medication and until the earliest of disease progres

Group	Value	95% CI
Part 1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	1

Duration of Objective Response Secondary · First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).

Group	Value	95% CI
Part 1: BI 836845 800 mg	145	NA – NA
Part 1: BI 836845 1050 mg	213	NA – NA

Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 Secondary · First treatment administration until disease progression or last evaluable assessment in absence of progression; Up to 72 weeks

Number of patients with best overall response. Best overall response represented the best response (complete response - CR, partial response - PR, stable disease -SD, progressive disease - PD) a patient had during their time in the study from first administration of trial medication until the earliest date of progression, or the last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the ba

Group	Value	95% CI
Part1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	0

Group	Value	95% CI
Part1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	1

Group	Value	95% CI
Part1: BI 836845 10 mg	2
Part 1: BI 836845 20 mg	1
Part 1: BI 836845 40 mg	2
Part 1: BI 836845 60 mg	2
Part 1: BI 836845 90 mg	2
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	2
Part 1: BI 836845 300 mg	1
Part 1: BI 836845 450 mg	3
Part 1: BI 836845 600 mg	3
Part 1: BI 836845 800 mg	2
Part 1: BI 836845 1050 mg	0

SD≥24 weeks

Group	Value	95% CI
Part1: BI 836845 10 mg	2
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	1
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	0

Group	Value	95% CI
Part1: BI 836845 10 mg	1
Part 1: BI 836845 20 mg	2
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	1
Part 1: BI 836845 90 mg	1
Part 1: BI 836845 135 mg	2
Part 1: BI 836845 200 mg	1
Part 1: BI 836845 300 mg	2
Part 1: BI 836845 450 mg	3
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	2

Not evaluable

Group	Value	95% CI
Part1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	1
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	1
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	2
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	0

Disease Control Secondary · First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Number of patients with Disease control. Disease control was defined as best overall response of CR, PR or SD \>24 week, with no confirmation required.

Group	Value	95% CI
Part 1: BI 836845 10 mg	2
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	1
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	1

Part 2 - Biopsiable Tumours: Progression-free Survival (PFS) Secondary · First treatment administration until tumour progression or death. Up to 72 weeks

PFS was evaluated only for cohort 2 (Biopsiable tumors) in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier. Median duration along with 95% confidence interval is based on Kaplan-Meier method.

Group	Value	95% CI
Part 2: Biopsiable Tumours	118.0	18.0 – 504.0

Maximum Measured Concentration of the BI 836845 in Plasma (Cmax) Secondary · Up to 337 hours. Detailed timeframe is in the description.

Maximum measured concentration of the BI 836845 in plasma (Cmax). Geometric mean (gMean) and Geometric coefficient of variation (gCV) is presented for each course. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe ap

Course 1

Group	Value	95% CI
Part 1: BI 836845 10 mg	2.87	± 23.8
Part 1: BI 836845 20 mg	6.53	± 14.9
Part 1: BI 836845 40 mg	13.8	± 26.6
Part 1: BI 836845 60 mg	22.2	± 3.78
Part 1: BI 836845 90 mg	28.2	± 28.7
Part 1: BI 836845 135 mg	36.6	± 20.6
Part 1: BI 836845 200 mg	70.8	± 26.7
Part 1: BI 836845 300 mg	81.9	± 42.2
Part 1: BI 836845 450 mg	151	± 16.7
Part 1: BI 836845 600 mg	199	± 10.8
Part 1: BI 836845 800 mg	200	± 38.1
Part 1: BI 836845 1050 mg	270	± 38.9

Course 2

Group	Value	95% CI
Part 1: BI 836845 10 mg	3.34	± 31.9
Part 1: BI 836845 20 mg	7.92	± 24.8
Part 1: BI 836845 40 mg	22.4	± 23.9
Part 1: BI 836845 60 mg	26.9	± 17.1
Part 1: BI 836845 90 mg	36.6	± 19.4
Part 1: BI 836845 135 mg	55.2	± 29.8
Part 1: BI 836845 200 mg	99.2	± 28.5
Part 1: BI 836845 300 mg	100	± 21.8
Part 1: BI 836845 450 mg	193	± 18.0
Part 1: BI 836845 600 mg	285	± 11.7
Part 1: BI 836845 800 mg	282	± 40.3
Part 1: BI 836845 1050 mg	393	± 39.1

Course 3

Group	Value	95% CI
Part 1: BI 836845 10 mg	NA	± NA
Part 1: BI 836845 20 mg	NA	± NA
Part 1: BI 836845 40 mg	NA	± NA
Part 1: BI 836845 60 mg	NA	± NA
Part 1: BI 836845 90 mg	NA	± NA
Part 1: BI 836845 135 mg	NA	± NA
Part 1: BI 836845 200 mg	NA	± NA
Part 1: BI 836845 300 mg	NA	± NA
Part 1: BI 836845 450 mg	NA	± NA
Part 1: BI 836845 600 mg	NA	± NA
Part 1: BI 836845 800 mg	NA	± NA
Part 1: BI 836845 1050 mg	NA	± NA

Course 4

Group	Value	95% CI
Part 1: BI 836845 10 mg	3.96	± 53.9
Part 1: BI 836845 20 mg	5.27	± NA
Part 1: BI 836845 40 mg	18.8	± 1.88
Part 1: BI 836845 60 mg	28.5	± NA
Part 1: BI 836845 90 mg	39.6	± 15.2
Part 1: BI 836845 200 mg	86.8	± NA
Part 1: BI 836845 450 mg	201	± 10.9
Part 1: BI 836845 600 mg	279	± 28.6
Part 1: BI 836845 800 mg	253	± 36.3
Part 1: BI 836845 1050 mg	615	± NA
Part 1: BI 836845 1400 mg	612	± NA
Part 1: BI 836845 1800 mg	739	± NA

Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax) Secondary · Up to 337 hours. Detailed timeframe is in the description.

Time to maximum measured concentration of the BI 836845 in plasma (tmax). As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.

Course 1

Group	Value	95% CI
BI 836845 10 mg	2.10	1.15 – 4.00
BI 836845 20 mg	2.02	1.75 – 6.38
BI 836845 40 mg	2.03	2.00 – 2.03
BI 836845 60 mg	1.13	1.03 – 1.92
BI 836845 90 mg	2.00	1.80 – 7.00
BI 836845 135 mg	1.05	1.03 – 1.92
BI 836845 200 mg	2.00	2.00 – 3.77
BI 836845 300 mg	2.25	2.07 – 2.28
BI 836845 450 mg	1.18	1.02 – 7.00
BI 836845 600 mg	2.00	1.92 – 2.25
BI 836845 800 mg	1.25	1.07 – 2.00
BI 836845 1050 mg	1.17	1.02 – 4.02

Course 2

Group	Value	95% CI
BI 836845 10 mg	0.967	0.967 – 2.03
BI 836845 20 mg	7.00	0.967 – 24.1
BI 836845 40 mg	1.50	1.00 – 2.00
BI 836845 60 mg	2.00	0.983 – 2.00
BI 836845 90 mg	2.15	1.00 – 4.00
BI 836845 135 mg	2.89	1.03 – 4.75
BI 836845 200 mg	2.97	2.00 – 7.00
BI 836845 300 mg	1.45	1.05 – 2.02
BI 836845 450 mg	1.12	1.05 – 2.02
BI 836845 600 mg	2.07	1.12 – 5.95
BI 836845 800 mg	1.83	1.40 – 2.00
BI 836845 1050 mg	4.00	3.95 – 4.00

Course 3

Group	Value	95% CI
BI 836845 10 mg	NA	NA – NA
BI 836845 20 mg	NA	NA – NA
BI 836845 40 mg	NA	NA – NA
BI 836845 60 mg	NA	NA – NA
BI 836845 90 mg	NA	NA – NA
BI 836845 135 mg	NA	NA – NA
BI 836845 200 mg	NA	NA – NA
BI 836845 300 mg	NA	NA – NA
BI 836845 450 mg	NA	NA – NA
BI 836845 600 mg	NA	NA – NA
BI 836845 800 mg	NA	NA – NA
BI 836845 1050 mg	NA	NA – NA

Course 4

Group	Value	95% CI
BI 836845 10 mg	3.33	1.75 – 4.90
BI 836845 20 mg	2.23	NA – NA
BI 836845 40 mg	1.54	1.08 – 2.00
BI 836845 60 mg	1.02	NA – NA
BI 836845 90 mg	3.09	2.18 – 4.00
BI 836845 200 mg	1.22	NA – NA
BI 836845 450 mg	2.00	1.63 – 7.00
BI 836845 600 mg	2.00	1.17 – 3.97
BI 836845 800 mg	1.00	1.00 – 1.00
BI 836845 1050 mg	4.00	NA – NA
BI 836845 1400 mg	2.00	NA – NA
BI 836845 1800 mg	2.00	NA – NA

Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168) Secondary · Up to 337 hours. Detailed timeframe is in the description.

Area under the plasma concentration-time curve from time 0 to 168 hours (AUC 0-168) of the BI 836845. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337

Course 1

Group	Value	95% CI
BI 836845 10 mg	249	± 37.2
BI 836845 20 mg	390	± 32.9
BI 836845 40 mg	752	± 66.3
BI 836845 60 mg	1300	± 42.5
BI 836845 90 mg	2250	± 16.7
BI 836845 135 mg	3050	± 17.7
BI 836845 200 mg	5950	± 26.9
BI 836845 300 mg	5680	± 23.1
BI 836845 450 mg	10600	± 12.6
BI 836845 600 mg	15600	± 7.09
BI 836845 800 mg	14500	± 45.6
BI 836845 1050 mg	31100	± 64.9

Course 2

Group	Value	95% CI
BI 836845 10 mg	265	± 49.6
BI 836845 20 mg	627	± 41.8
BI 836845 40 mg	1950	± NA
BI 836845 60 mg	1790	± NA
BI 836845 90 mg	3390	± 27.7
BI 836845 135 mg	5150	± 52.2
BI 836845 200 mg	9490	± 11.1
BI 836845 300 mg	9480	± 3.39
BI 836845 450 mg	15997	± 24.1
BI 836845 600 mg	21400	± 13.0
BI 836845 800 mg	22000	± 46.3
BI 836845 1050 mg	38600	± 34.0

Course 3

Group	Value	95% CI
BI 836845 10 mg	NA	± NA
BI 836845 20 mg	NA	± NA
BI 836845 40 mg	NA	± NA
BI 836845 60 mg	NA	± NA
BI 836845 90 mg	NA	± NA
BI 836845 135 mg	NA	± NA
BI 836845 200 mg	NA	± NA
BI 836845 300 mg	NA	± NA
BI 836845 450 mg	NA	± NA
BI 836845 600 mg	NA	± NA
BI 836845 800 mg	NA	± NA
BI 836845 1050 mg	NA	± NA

Course 4

Group	Value	95% CI
BI 836845 10 mg	309	± 132
BI 836845 20 mg	337	± NA
BI 836845 40 mg	1780	± NA
BI 836845 60 mg	4010	± NA
BI 836845 90 mg	3620	± 3.91
BI 836845 200 mg	10300	± NA
BI 836845 450 mg	14300	± NA
BI 836845 600 mg	17900	± NA
BI 836845 800 mg	19000	± 78.8
BI 836845 1050 mg	56600	± NA
BI 836845 1400 mg	52400	± NA
BI 836845 1800 mg	67400	± NA

Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Secondary · First treatment administration until end of treatment plus residual effect period; Up to 74 weeks

Number of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The intensity of AEs was defined based on: * Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which is/are easily tolerated. * Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity. * Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities. * Grade 4 - Life-threatening or disabling AE. * Grade 5 - Death related to AE.

Grade 1

Group	Value	95% CI
Part 1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	1
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	1
Part 1: BI 836845 135 mg	2
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	1
Part 1: BI 836845 450 mg	2
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	1

Grade 2

Group	Value	95% CI
Part 1: BI 836845 10 mg	2
Part 1: BI 836845 20 mg	1
Part 1: BI 836845 40 mg	1
Part 1: BI 836845 60 mg	1
Part 1: BI 836845 90 mg	1
Part 1: BI 836845 135 mg	1
Part 1: BI 836845 200 mg	1
Part 1: BI 836845 300 mg	1
Part 1: BI 836845 450 mg	4
Part 1: BI 836845 600 mg	2
Part 1: BI 836845 800 mg	2
Part 1: BI 836845 1050 mg	1

Grade 3

Group	Value	95% CI
Part 1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	1
Part 1: BI 836845 60 mg	1
Part 1: BI 836845 90 mg	1
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	2
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	2
Part 1: BI 836845 600 mg	1
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	1

Grade 4

Group	Value	95% CI
Part 1: BI 836845 10 mg	1
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	0
Part 1: BI 836845 60 mg	0
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	1
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	1
Part 1: BI 836845 1050 mg	0

Grade 5

Group	Value	95% CI
Part 1: BI 836845 10 mg	0
Part 1: BI 836845 20 mg	0
Part 1: BI 836845 40 mg	1
Part 1: BI 836845 60 mg	1
Part 1: BI 836845 90 mg	0
Part 1: BI 836845 135 mg	0
Part 1: BI 836845 200 mg	0
Part 1: BI 836845 300 mg	0
Part 1: BI 836845 450 mg	0
Part 1: BI 836845 600 mg	0
Part 1: BI 836845 800 mg	0
Part 1: BI 836845 1050 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: First treatment administration until end of treatment plus residual effect period; Up to 74 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: BI 836845 10 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 20 mg

Serious: 0/3 (0%)

Deaths: —

Part 1: BI 836845 40 mg

Serious: 2/3 (67%)

Deaths: —

Part 1: BI 836845 60 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 90 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 135 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 200 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 300 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 450 mg

Serious: 3/8 (38%)

Deaths: —

Part 1: BI 836845 600 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 800 mg

Serious: 2/4 (50%)

Deaths: —

Part 1: BI 836845 1050 mg

Serious: 0/3 (0%)

Deaths: —

Part 1: BI 836845 1400 mg

Serious: 1/3 (33%)

Deaths: —

Part 1: BI 836845 1800 mg

Serious: 2/3 (67%)

Deaths: —

Part 2: Ewing's Sarcoma Family of Tumours

Serious: 0/1 (0%)

Deaths: —

Part 2: Biopsiable Tumours

Serious: 4/12 (33%)

Deaths: —

Serious adverse events (38 terms)

Reaction	System	Part 1: BI 836845 10 mg	Part 1: BI 836845 20 mg	Part 1: BI 836845 40 mg	Part 1: BI 836845 60 mg	Part 1: BI 836845 90 mg	Part 1: BI 836845 135 mg	Part 1: BI 836845 200 mg	Part 1: BI 836845 300 mg	Part 1: BI 836845 450 mg	Part 1: BI 836845 600 mg	Part 1: BI 836845 800 mg	Part 1: BI 836845 1050 mg	Part 1: BI 836845 1400 mg	Part 1: BI 836845 1800 mg	Part 2: Ewing's Sarcoma Fa…	Part 2: Biopsiable Tumours
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diabetes insipidus	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal mucosal disorder	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Liver abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peritonitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subdural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (136 terms — click to expand)

Reaction	System	Part 1: BI 836845 10 mg	Part 1: BI 836845 20 mg	Part 1: BI 836845 40 mg	Part 1: BI 836845 60 mg	Part 1: BI 836845 90 mg	Part 1: BI 836845 135 mg	Part 1: BI 836845 200 mg	Part 1: BI 836845 300 mg	Part 1: BI 836845 450 mg	Part 1: BI 836845 600 mg	Part 1: BI 836845 800 mg	Part 1: BI 836845 1050 mg	Part 1: BI 836845 1400 mg	Part 1: BI 836845 1800 mg	Part 2: Ewing's Sarcoma Fa…	Part 2: Biopsiable Tumours
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epigastric discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cachexia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pelvic pain	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Pyrexia, Hepatic function abnormal, Device related infection, Pneumonia, Urinary tract infection, Dyspnoea, Pneumonia aspiration.

Data from ClinicalTrials.gov NCT01403974 adverse events section.

Sponsor's own description

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients. The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).

Publications & conference data

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

Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways.
Hosford SR, Miller TW. · · 2014 · cited 109× · PMID 25206307 · DOI 10.2147/pgpm.s52762
Present Advances and Future Perspectives of Molecular Targeted Therapy for Osteosarcoma.
Shaikh AB, Li F, Li M, He B, et al · · 2016 · cited 89× · PMID 27058531 · DOI 10.3390/ijms17040506
Strategies for modern biomarker and drug development in oncology.
Smith AD, Roda D, Yap TA. · · 2014 · cited 89× · PMID 25277503 · DOI 10.1186/s13045-014-0070-8
Obesity and endocrine-related cancer: The important role of IGF-1.
Zhong W, Wang X, Wang Y, Sun G, et al · · 2023 · cited 44× · PMID 36755926 · DOI 10.3389/fendo.2023.1093257
Two first-in-human studies of xentuzumab, a humanised insulin-like growth factor (IGF)-neutralising antibody, in patients with advanced solid tumours.
de Bono J, Lin CC, Chen LT, Corral J, et al · · 2020 · cited 34× · PMID 32161368 · DOI 10.1038/s41416-020-0774-1
Enhanced anti-metastatic bioactivity of an IGF-TRAP re-engineered to improve physicochemical properties.
Vaniotis G, Moffett S, Sulea T, Wang N, et al · · 2018 · cited 15× · PMID 30478273 · DOI 10.1038/s41598-018-35407-2

Verify or expand the search:

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Trials testing the same drug.

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01403974 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 25 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01403974.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01403974

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (38 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of BI 836845

Other recruiting trials for Neoplasms

Other Boehringer Ingelheim trials

Verify against primary sources