Trial · NCT02401542
Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
NCT02401542, Phase 1, Phase 2, Terminated, Rainier Therapeutics; results first posted 2020-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma. Trials, record NCT02401542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02401542
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
- NCT number
- NCT02401542
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Rainier Therapeutics
- Conditions
- Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
- Interventions
- Vofatamab, Docetaxel, Placebo
- First posted
- 2015-03-30
- Last updated
- 2020-03-09
- Other registries' IDs
- eudract:2017-001319-36
- Results first posted
- 2020-02-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Efficacy Outcome: Progression Free Survival (PFS) | 3-4 years | Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
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 | Primary Efficacy Outcome: Progression Free Survival (PFS) | 3-4 years | Months | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Efficacy Outcome: Progression Free Survival (PFS) | Mut/Fus Phase 1 | 6.82 | Standard Deviation 5.35 | Months | |
| Primary Efficacy Outcome: Progression Free Survival (PFS) | Wild Type Phase 1 | 2.83 | Standard Deviation 2.73 | Months | |
| Primary Efficacy Outcome: Progression Free Survival (PFS) | Mut/Fus Phase 2 | 4.40 | Standard Deviation 4.15 | Months | |
| Primary Efficacy Outcome: Progression Free Survival (PFS) | Mut/Fus Phase 2 Monotherapy | 4.45 | Standard Deviation 3.27 | Months | |
| Primary Efficacy Outcome: Progression Free Survival (PFS) | Mut/Fus Phase 2b Monotherapy | 2.23 | Standard Deviation 1.45 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vofatamab Plus Docetaxel | 41 | |
| Overall Study | STARTED | Vofatamab | 30 | |
| Overall Study | STARTED | Placebo Plus Docetaxel | 0 | |
| Overall Study | COMPLETED | Vofatamab Plus Docetaxel | 40 | |
| Overall Study | COMPLETED | Vofatamab | 30 | |
| Overall Study | COMPLETED | Placebo Plus Docetaxel | 0 | |
| Overall Study | NOT COMPLETED | Vofatamab Plus Docetaxel | 1 | |
| Overall Study | NOT COMPLETED | Vofatamab | 0 | |
| Overall Study | NOT COMPLETED | Placebo Plus Docetaxel | 0 |
Source ClinicalTrials.gov
Adverse events999
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 | Abdominal pain | Gastrointestinal disorders | Vofatamab Plus Docetaxel | 9 | 40 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Vofatamab | 1 | 30 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Docetaxel | 0 | ||
| other | Abdominal tenderness | Gastrointestinal disorders | Vofatamab Plus Docetaxel | 1 | 40 | 1 |
| other | Abdominal tenderness | Gastrointestinal disorders | Vofatamab | 0 | 30 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | Placebo Plus Docetaxel | 0 | ||
| other | Abnormal ECG | Investigations | Vofatamab Plus Docetaxel | 0 | 40 | 0 |
| other | Abnormal ECG | Investigations | Vofatamab | 1 | 30 | 1 |
| other | Abnormal ECG | Investigations | Placebo Plus Docetaxel | 0 | ||
| other | Absolute neutrophil count decreased | Investigations | Vofatamab Plus Docetaxel | 1 | 40 | 1 |
1 to 10 of 999Source ClinicalTrials.gov
See all 999 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vofatamab Plus Docetaxel | 2 | 40 |
| Total, all-cause mortality | Vofatamab | 1 | 30 |
| Total, all-cause mortality | Placebo Plus Docetaxel | 0 | 0 |
| Total, other adverse events | Vofatamab Plus Docetaxel | 40 | 40 |
| Total, other adverse events | Vofatamab | 30 | 30 |
| Total, other adverse events | Placebo Plus Docetaxel | 0 | 0 |
| Total, serious adverse events | Vofatamab Plus Docetaxel | 21 | 40 |
| Total, serious adverse events | Vofatamab | 6 | 30 |
| Total, serious adverse events | Placebo Plus Docetaxel | 0 | 0 |
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 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/NCT02401542
GET https://conductscience.org/api/trials/v1/NCT02401542/events?page=2