Trial · NCT02713828
Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung
NCT02713828, Phase 1, Phase 2, Terminated, PrECOG, LLC.; results first posted 2019-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung. Trials, record NCT02713828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02713828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung
- NCT number
- NCT02713828
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- PrECOG, LLC.
- Conditions
- Squamous Cell Carcinoma of the Lung
- Interventions
- Phase I: Glembatumumab Vedotin, Phase II: Glembatumumab Vedotin
- First posted
- 2016-03-21
- Last updated
- 2019-07-16
- Results first posted
- 2019-07-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Determine Maximum Tolerated Dose (MTD) | 42 (±3) days | To determine the Maximum Tolerated Dose (MTD) by number of participants with DLTs. |
| Primary | Phase II: Objective Response Rate (ORR) | 40 months | Determine the anti-tumor activity, as assessed by ORR in accordance with RECIST 1.1, of the MTD of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung. |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0. | 23 months | To further characterize the safety of glembatumumab vedotin by the number of participants with abnormal laboratory values and/or adverse events related to treatment (including Serious Adverse Events and Other Adverse Events). |
| Secondary | Duration of Objective Response (DOR) | 23 months | DOR assessed in accordance with RECIST 1.1. |
| Secondary | Progression-Free Survival (PFS) | 23 months | PFS assessed in accordance with RECIST 1.1. |
| Secondary | Overall Survival (OS) | 23 months | OS assessed in accordance with RECIST 1.1. |
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 | Phase I: Determine Maximum Tolerated Dose (MTD) | 42 (±3) days | mg/kg | NUMBER | |
| PRIMARY | Phase II: Objective Response Rate (ORR) | 40 months | The study terminated early during the phase I portion of the trial | ||
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0. | 23 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Objective Response (DOR) | 23 months | 1 patient achieved partial response. The duration of this patient's response is at least 9.4 months, with response ongoing at the time of final report. | months | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | 23 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 23 months | months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Phase I: Determine Maximum Tolerated Dose (MTD) | Phase I: Glembatumumab Vedotin | NA | mg/kg | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0. | Phase I: Glembatumumab Vedotin | 13 | Participants | ||
| Duration of Objective Response (DOR) | Phase I: Glembatumumab Vedotin | 9.4 | months | ||
| Progression-Free Survival (PFS) | Phase I: Glembatumumab Vedotin | 2.5 | 95% Confidence Interval 1.6 to NA | months | |
| Overall Survival (OS) | Phase I: Glembatumumab Vedotin | 5.8 | 95% Confidence Interval 2.5 to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: Glembatumumab Vedotin | 13 | |
| Overall Study | STARTED | Phase II: Glembatumumab Vedotin | 0 | |
| Overall Study | COMPLETED | Phase I: Glembatumumab Vedotin | 8 | |
| Overall Study | COMPLETED | Phase II: Glembatumumab Vedotin | 0 | |
| Overall Study | NOT COMPLETED | Phase I: Glembatumumab Vedotin | 5 | |
| Overall Study | NOT COMPLETED | Phase II: Glembatumumab Vedotin | 0 |
Source ClinicalTrials.gov
Adverse events47
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 | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Metabolism and nutrition disorders Dehydration | Metabolism and nutrition disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Dry mouth | Gastrointestinal disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Dysgeusia | Nervous system disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Rash papular | Skin and subcutaneous tissue disorders | Phase I: Glembatumumab Vedotin | 1 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Phase I: Glembatumumab Vedotin | 2 | 13 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase I: Glembatumumab Vedotin | 1 | 13 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Glembatumumab Vedotin | 7 | 13 |
| Total, other adverse events | Phase I: Glembatumumab Vedotin | 8 | 13 |
| Total, serious adverse events | Phase I: Glembatumumab Vedotin | 9 | 13 |
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/NCT02713828
GET https://conductscience.org/api/trials/v1/NCT02713828/events?page=2