Trial · NCT01907100
Nintedanib (BIBF 1120) in Mesothelioma
NCT01907100, Phase 2, Phase 3, Terminated, Boehringer Ingelheim; results first posted 2019-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nintedanib (BIBF 1120) in Mesothelioma. Trials, record NCT01907100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01907100
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nintedanib (BIBF 1120) in Mesothelioma
- NCT number
- NCT01907100
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 545 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Mesothelioma
- Interventions
- Nintedanib, Pemetrexed, Cisplatin, Cisplatin, Pemetrexed, Placebo
- First posted
- 2013-07-24
- Last updated
- 2019-03-18
- Other registries' IDs
- eudract:2012-005201-48
- Results first posted
- 2019-03-18
- Limitations and caveats
In accordance with the specifications in the protocol, the trial was discontinued prematurely after the primary PFS analysis not because of any safety concerns but rather due to failure to meet the efficacy target.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) | This outcome measure presents progression-free survival. Disease progression was defined according to the modified 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 occurred 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. |
| Secondary | Overall Survival (OS) | From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) | Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial. |
| Secondary | Objective Response According to Modified RECIST- Investigator Assessment | Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months | Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part. |
| Secondary | Disease Control According to Modified RECIST- Investigator Assessment | Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months | Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) | Randomised Set: This patient set included all randomized patients. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) | Randomised Set: This patient set included all randomized patients. | Months | MEDIAN |
| SECONDARY | Objective Response According to Modified RECIST- Investigator Assessment | Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months | Randomised Set: This patient set included all randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control According to Modified RECIST- Investigator Assessment | Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months | Randomised Set: This patient set included all randomized patients. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Placebo | Phase II | 5.72 | Inter-Quartile Range 5.19 to 8.18 | Months |
| Progression-Free Survival (PFS) | Nintedanib | Phase II | 9.36 | Inter-Quartile Range 5.55 to 12.65 | Months |
| Progression-Free Survival (PFS) | Placebo | Phase III | 6.97 | Inter-Quartile Range 5.42 to 9.00 | Months |
| Progression-Free Survival (PFS) | Nintedanib | Phase III | 6.77 | Inter-Quartile Range 5.36 to 9.07 | Months |
| Overall Survival (OS) | Placebo | Phase II | 14.46 | Inter-Quartile Range 10.41 to NA | Months |
| Overall Survival (OS) | Nintedanib | Phase II | 18.30 | Inter-Quartile Range 10.91 to NA | Months |
| Overall Survival (OS) | Placebo | Phase III | 16.07 | Inter-Quartile Range 9.66 to 19.29 | Months |
| Overall Survival (OS) | Nintedanib | Phase III | 14.36 | Inter-Quartile Range 9.13 to 18.69 | Months |
| Objective Response According to Modified RECIST- Investigator Assessment | Placebo | 42.8 | 95% Confidence Interval 36.3 to 49.5 | Percentage of participants | |
| Objective Response According to Modified RECIST- Investigator Assessment | Nintedanib | 45.0 | 95% Confidence Interval 38.4 to 51.7 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo_Phase II | 43 | |
| Overall Study | STARTED | Nintedanib_Phase II | 44 | |
| Overall Study | STARTED | Placebo_Phase III | 229 | |
| Overall Study | STARTED | Nintedanib_Phase III | 229 | |
| Overall Study | Treated Patients | Placebo_Phase II | 41 | |
| Overall Study | Treated Patients | Nintedanib_Phase II | 44 | |
| Overall Study | Treated Patients | Placebo_Phase III | 228 | |
| Overall Study | Treated Patients | Nintedanib_Phase III | 227 | |
| Overall Study | COMPLETED | Placebo_Phase II | 1 | |
| Overall Study | COMPLETED | Nintedanib_Phase II | 4 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events976
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 | Placebo_Phase II | 9 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib_Phase II | 16 | 44 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo_Phase III | 94 | 228 | |
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib_Phase III | 76 | 227 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo_Phase II | 5 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib_Phase II | 2 | 44 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo_Phase III | 28 | 228 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib_Phase III | 20 | 227 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo_Phase II | 9 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib_Phase II | 22 | 44 |
1 to 10 of 976Source ClinicalTrials.gov
See all 976 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo_Phase II | 25 | 43 |
| Total, all-cause mortality | Nintedanib_Phase II | 22 | 44 |
| Total, all-cause mortality | Placebo_Phase III | 63 | 229 |
| Total, all-cause mortality | Nintedanib_Phase III | 64 | 229 |
| Total, other adverse events | Placebo_Phase II | 41 | 41 |
| Total, other adverse events | Nintedanib_Phase II | 44 | 44 |
| Total, other adverse events | Placebo_Phase III | 219 | 228 |
| Total, other adverse events | Nintedanib_Phase III | 218 | 227 |
| Total, serious adverse events | Placebo_Phase II | 17 | 41 |
| Total, serious adverse events | Nintedanib_Phase II | 16 | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31103412 | 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/NCT01907100
GET https://conductscience.org/api/trials/v1/NCT01907100/events?page=2