Trial · NCT01997333
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
NCT01997333, Phase 2, Completed, Celldex Therapeutics; results first posted 2019-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer. Trials, record NCT01997333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01997333
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
- NCT number
- NCT01997333
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 327 participants, actual
- Lead sponsor
- Celldex Therapeutics
- Conditions
- Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
- Interventions
- CDX-011, Capecitabine
- First posted
- 2013-11-28
- Last updated
- 2019-03-08
- Results first posted
- 2019-03-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Evaluated every 6 - 9 weeks following treatment initiation | PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease 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 progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. |
| Secondary | Objective Response Rate (ORR) | Evaluated every 6 - 9 weeks following treatment initiation | ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. |
| Secondary | Duration of Response | Evaluated every 6 - 9 weeks following treatment initiation | Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. |
| Secondary | Overall Survival | During treatment and 3 months from end of treatment through end of study or approximately up to 5 years. | Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause. |
| Secondary | Adverse Events (AE) | Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up) | The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity. |
| Secondary | Pharmacokinetics (PK) | Following 1 dose of CDX-011. | Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined. |
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 | Progression Free Survival (PFS) | Evaluated every 6 - 9 weeks following treatment initiation | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | Evaluated every 6 - 9 weeks following treatment initiation | Patients with measurable disease. | percentage of participants | MEDIAN |
| SECONDARY | Duration of Response | Evaluated every 6 - 9 weeks following treatment initiation | months | MEDIAN | |
| SECONDARY | Overall Survival | During treatment and 3 months from end of treatment through end of study or approximately up to 5 years. | months | MEDIAN | |
| SECONDARY | Adverse Events (AE) | Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics (PK) | Following 1 dose of CDX-011. | Samples were obtained from 201 of 213 patients treated with CDX-011. A partial analysis provided below results. Additional analyses were not completed. Results should be interpreted with caution. | ug/ml | MEAN |
Source ClinicalTrials.gov
Results by group25
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) | Capecitabine | 2.8 | 95% Confidence Interval 1.6 to 3.2 | months | |
| Progression Free Survival (PFS) | CDX-011 | 2.9 | 95% Confidence Interval 2.8 to 3.5 | months | |
| Objective Response Rate (ORR) | Capecitabine | 21 | 95% Confidence Interval 14 to 30 | percentage of participants | |
| Objective Response Rate (ORR) | CDX-011 | 26 | 95% Confidence Interval 20 to 33 | percentage of participants | |
| Duration of Response | Capecitabine | 4.2 | 95% Confidence Interval 2.7 to 5.6 | months | |
| Duration of Response | CDX-011 | 2.8 | 95% Confidence Interval 2.3 to 5.5 | months | |
| Overall Survival | Capecitabine | 8.7 | 95% Confidence Interval 6.9 to 10.8 | months | |
| Overall Survival | CDX-011 | 8.9 | 95% Confidence Interval 7.9 to 10.5 | months | |
| Adverse Events (AE) | Capecitabine | Patients with at least 1 AE | 92 | Participants | |
| Adverse Events (AE) | CDX-011 | Patients with at least 1 AE | 211 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization and Treatment | STARTED | Capecitabine | 109 | |
| Randomization and Treatment | STARTED | CDX-011 | 218 | |
| Randomization and Treatment | COMPLETED | Capecitabine | 6 | |
| Randomization and Treatment | COMPLETED | CDX-011 | 15 | |
| Randomization and Treatment | NOT COMPLETED | Capecitabine | 103 | |
| Randomization and Treatment | NOT COMPLETED | CDX-011 | 203 | |
| Survival Follow up | STARTED | Capecitabine | 92 | |
| Survival Follow up | STARTED | CDX-011 | 213 | |
| Survival Follow up | COMPLETED | Capecitabine | 76 | |
| Survival Follow up | COMPLETED | CDX-011 | 199 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events352
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 | Capecitabine | 9 | 92 | |
| other | Anaemia | Blood and lymphatic system disorders | CDX-011 | 33 | 213 | |
| other | Neutropenia | Blood and lymphatic system disorders | Capecitabine | 5 | 92 | |
| other | Neutropenia | Blood and lymphatic system disorders | CDX-011 | 49 | 213 | |
| other | Abdominal distension | Gastrointestinal disorders | Capecitabine | 3 | 92 | |
| other | Abdominal distension | Gastrointestinal disorders | CDX-011 | 12 | 213 | |
| other | Abdominal pain | Gastrointestinal disorders | Capecitabine | 16 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | CDX-011 | 22 | 213 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Capecitabine | 6 | 92 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CDX-011 | 17 | 213 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine | 65 | 92 |
| Total, all-cause mortality | CDX-011 | 134 | 213 |
| Total, other adverse events | Capecitabine | 91 | 92 |
| Total, other adverse events | CDX-011 | 211 | 213 |
| Total, serious adverse events | Capecitabine | 19 | 92 |
| Total, serious adverse events | CDX-011 | 71 | 213 |
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 |
|---|---|
| Capecitabine vs CDX-011: deaths from any cause | Trial comparisons |
| Capecitabine vs CDX-011: 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/NCT01997333
GET https://conductscience.org/api/trials/v1/NCT01997333/results?page=2