Trial · NCT02145741
Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
NCT02145741, Phase 1, Completed, Boehringer Ingelheim; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours. Trials, record NCT02145741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02145741
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
- NCT number
- NCT02145741
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Neoplasms
- Interventions
- 750 milligram Xentuzumab, 1000 milligram Xentuzumab, 1400 milligram Xentuzumab
- First posted
- 2014-05-23
- Last updated
- 2025-06-19
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Xentuzumab in Japanese Patients With Advanced Solid Tumours, as Identified by the Number of Patients With Dose-limiting Toxicities (DLTs) | During the first cycle of treatment, up to 21 days of treatment. | MTD of xentuzumab in Japanese patients with advanced solid tumours, as identified by the number of patients with DLTs. The MTD of xentuzumab was defined as the highest dose tested with DLT occurring in not more than 1 out of 6 evaluable patients. DLTs were defined as: Haematological toxicities: Common Terminology Criteria for Adverse Events (CTCAE) grade (g) 4 neutropenia ≥7 days (d), select cases of Febrile neutropenia, Infections or CTCAE g4 thrombocytopenia or CTCAE g3 thrombocytopenia. Non-haematological toxicities: CTCAE grade 3 or 4 non-haematologic toxicity, with exceptions CTCAE grade≥2 infusion reaction or nausea and/or vomiting with exceptions CTCAE grade ≥3 skin toxicity, hyperglycaemia, any electrolyte adverse events (AE), fatigue or asthenia with exceptions No recovery from a non-DLT CTCAE g≥3 toxicity to g≤1 within 14 d of administered dose Other drug-related AEs (CTCAE g2), might qualify as a DLT, which will be determined on a case by case bases. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Xentuzumab in Japanese Patients With Advanced Solid Tumours, as Identified by the Number of Patients With Dose-limiting Toxicities (DLTs) | During the first cycle of treatment, up to 21 days of treatment. | The Maximum tolerated dose (MTD) set was defined as the set of patients that were fully evaluable for the MTD in the first treatment cycle. | Milligram | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Xentuzumab in Japanese Patients With Advanced Solid Tumours, as Identified by the Number of Patients With Dose-limiting Toxicities (DLTs) | Xentuzumab (BI 836845) | NA | Milligram |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 750 Milligram Xentuzumab (BI 836845) | 6 | |
| Overall Study | STARTED | 1000 Milligram Xentuzumab (BI 836845) | 9 | |
| Overall Study | STARTED | 1400 Milligram Xentuzumab (BI 836845) | 6 | |
| Overall Study | Maximum Tolerated Dose (MTD) Set | 750 Milligram Xentuzumab (BI 836845) | 3 | |
| Overall Study | Maximum Tolerated Dose (MTD) Set | 1000 Milligram Xentuzumab (BI 836845) | 3 | |
| Overall Study | Maximum Tolerated Dose (MTD) Set | 1400 Milligram Xentuzumab (BI 836845) | 6 | |
| Overall Study | COMPLETED | 750 Milligram Xentuzumab (BI 836845) | 0 | |
| Overall Study | COMPLETED | 1000 Milligram Xentuzumab (BI 836845) | 3 | |
| Overall Study | COMPLETED | 1400 Milligram Xentuzumab (BI 836845) | 0 | |
| Overall Study | NOT COMPLETED | 750 Milligram Xentuzumab (BI 836845) | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events231
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 750 Milligram Xentuzumab (BI 836845) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | 1000 Milligram Xentuzumab (BI 836845) | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | 1400 Milligram Xentuzumab (BI 836845) | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | 750 Milligram Xentuzumab (BI 836845) | 2 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | 1000 Milligram Xentuzumab (BI 836845) | 2 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | 1400 Milligram Xentuzumab (BI 836845) | 0 | 6 | |
| other | Hypothyroidism | Endocrine disorders | 750 Milligram Xentuzumab (BI 836845) | 0 | 6 | |
| other | Hypothyroidism | Endocrine disorders | 1000 Milligram Xentuzumab (BI 836845) | 1 | 9 | |
| other | Hypothyroidism | Endocrine disorders | 1400 Milligram Xentuzumab (BI 836845) | 0 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | 750 Milligram Xentuzumab (BI 836845) | 0 | 6 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 750 Milligram Xentuzumab (BI 836845) | 0 | 6 |
| Total, all-cause mortality | 1000 Milligram Xentuzumab (BI 836845) | 0 | 9 |
| Total, all-cause mortality | 1400 Milligram Xentuzumab (BI 836845) | 0 | 6 |
| Total, other adverse events | 750 Milligram Xentuzumab (BI 836845) | 3 | 6 |
| Total, other adverse events | 1000 Milligram Xentuzumab (BI 836845) | 9 | 9 |
| Total, other adverse events | 1400 Milligram Xentuzumab (BI 836845) | 6 | 6 |
| Total, serious adverse events | 750 Milligram Xentuzumab (BI 836845) | 0 | 6 |
| Total, serious adverse events | 1000 Milligram Xentuzumab (BI 836845) | 3 | 9 |
| Total, serious adverse events | 1400 Milligram Xentuzumab (BI 836845) | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34870878 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02145741
GET https://conductscience.org/api/trials/v1/NCT02145741/events?page=2