Trial · NCT02999672
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
NCT02999672, Phase 2, Completed, Hoffmann-La Roche; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors. Trials, record NCT02999672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02999672
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
- NCT number
- NCT02999672
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Bladder Cancer, Pancreas Cancer, Cholangiocellular Carcinoma
- Interventions
- Trastuzumab Emtansine
- First posted
- 2016-12-21
- Last updated
- 2019-08-28
- Other registries' IDs
- eudract:2015-001377-40
- Results first posted
- 2019-08-28
- Limitations and caveats
- The results represent the data up to primary completion date (10 April 2018). However, due to the early termination, the study was unable to fully address its primary and secondary objectives.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported. |
| Secondary | Progression-Free Survival (PFS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. |
| Secondary | Overall Survival (OS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | OS was determined as the time from beginning of treatment to death from any cause. |
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 18 months | Incidence, type and severity of all adverse events (AEs) and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). |
| Secondary | Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria | Baseline up to approximately 18 months | Participants from both cohorts (UBC and Pancreatic cancer/cholangiocarcinoma) were analyzed for drug-induced liver injury following Hy's Law. Hy's Law criteria for potential drug-induced liver injury includes an elevated ALT (alanine aminotransferase) or AST (aspartate aminotransferase) in combination with either elevated bilirubin or clinical jaundice. |
| Secondary | Plasma/Serum Concentrations of Trastuzumab Emtansine | Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days | Samples for evaluation of trastuzumab emtansine, DM1, and total trastuzumab were obtained from all participants from both cohorts at specified time points. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts | Percentage of Treated Participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 18 months | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria | Baseline up to approximately 18 months | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts | Percentage of Participants | NUMBER |
| SECONDARY | Plasma/Serum Concentrations of Trastuzumab Emtansine | Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days | Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Cohort 1 (UBC) | CR | 0 | Percentage of Treated Participants | |
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | CR | 0 | Percentage of Treated Participants | |
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Cohort 1 (UBC) | PR | 38.5 | Percentage of Treated Participants | |
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | PR | 14.3 | Percentage of Treated Participants | |
| Progression-Free Survival (PFS) | Cohort 1 (UBC) | 2.20 | 95% Confidence Interval 1.18 to 4.30 | Months | |
| Progression-Free Survival (PFS) | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 2.58 | 95% Confidence Interval 1.31 to 9.99 | Months | |
| Overall Survival (OS) | Cohort 1 (UBC) | 7.03 | 95% Confidence Interval 3.75 to NA | Months | |
| Overall Survival (OS) | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | NA | 95% Confidence Interval 1.45 to NA | Months | |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Cohort 1 (UBC) | AEs | 84.6 | Percentage of Participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | AEs | 100 | Percentage of Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (UBC) | 13 | |
| Overall Study | STARTED | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 7 | |
| Overall Study | COMPLETED | Cohort 1 (UBC) | 0 | |
| Overall Study | COMPLETED | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 (UBC) | 13 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 7 |
Source ClinicalTrials.gov
Adverse events168
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 | Cohort 1 (UBC) | 3 | 13 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 1 | 7 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1 (UBC) | 1 | 13 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 1 | 7 | 1 |
| other | Ventricular dysfunction | Cardiac disorders | Cohort 1 (UBC) | 1 | 13 | 1 |
| other | Ventricular dysfunction | Cardiac disorders | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 0 | 7 | 0 |
| other | Ascites | Gastrointestinal disorders | Cohort 1 (UBC) | 1 | 13 | 1 |
| other | Ascites | Gastrointestinal disorders | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 0 | 7 | 0 |
| other | Constipation | Gastrointestinal disorders | Cohort 1 (UBC) | 2 | 13 | 2 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 1 | 7 | 1 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (UBC) | 7 | 13 |
| Total, all-cause mortality | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 1 | 7 |
| Total, other adverse events | Cohort 1 (UBC) | 11 | 13 |
| Total, other adverse events | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 7 | 7 |
| Total, serious adverse events | Cohort 1 (UBC) | 6 | 13 |
| Total, serious adverse events | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (UBC) vs Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma): deaths from any cause | Trial comparisons |
| Cohort 1 (UBC) vs Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma): serious adverse events | Trial comparisons |
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/NCT02999672
GET https://conductscience.org/api/trials/v1/NCT02999672/results?page=2