Trial · NCT02471716
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
NCT02471716, Phase 1, Phase 2, Completed, Five Prime Therapeutics, Inc.; results first posted 2021-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor. Trials, record NCT02471716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02471716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
- NCT number
- NCT02471716
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Five Prime Therapeutics, Inc.
- Conditions
- Pigmented Villonodular Synovitis, Tenosynovial Giant Cell Tumor
- Interventions
- FPA008
- First posted
- 2015-06-15
- Last updated
- 2021-08-31
- Results first posted
- 2021-08-31
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 | 52 weeks | Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1 |
| Primary | The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) | 52 weeks | Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2) |
| Secondary | PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | 52 weeks | Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter |
| Secondary | Maximum Serum Concentration (Cmax). | 52 weeks | Composite PK parameters of cabiralizumab: Maximum observed serum concentration |
| Secondary | Minimum Serum Concentration (Cmin). | 52 weeks | Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin). |
| Secondary | Pharmacokinetic Clearance (CL). | 52 weeks | Composite PK parameters of cabiralizumab: clearance (CL) |
| Secondary | The Incidence of AEs. | 52 weeks | treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE. |
| Secondary | The Incidence of Clinical Laboratory Abnormalities. | 52 weeks | The number of patients with a clinical laboratory that is outside the normal range at some time point during the study |
| Secondary | The Incidence of ECG Abnormalities. | 52 weeks | The number of patients who had a change in their ECG that were clinically significant |
| Secondary | Duration of Response Per RECIST 1.1 in Phase 2 | 52 weeks | The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 | 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) | 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | 52 weeks | ug x day/mL | GEOMETRIC_MEAN | |
| SECONDARY | Maximum Serum Concentration (Cmax). | 52 weeks | ug/mL | GEOMETRIC_MEAN | |
| SECONDARY | Minimum Serum Concentration (Cmin). | 52 weeks | ug/mL | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetic Clearance (CL). | 52 weeks | L/d | GEOMETRIC_MEAN | |
| SECONDARY | The Incidence of AEs. | 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Incidence of Clinical Laboratory Abnormalities. | 52 weeks | participants | NUMBER | |
| SECONDARY | The Incidence of ECG Abnormalities. | 52 weeks | The changes in the ECG parameters were not clinically significant in any dosing cohort in the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response Per RECIST 1.1 in Phase 2 | 52 weeks | months | MEDIAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 | Phase 1 FPA008 Dose Escalation 1mg/kg | 0 | Participants | ||
| The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 | Phase 1 FPA008 Dose Escalation 2mg/kg | 0 | Participants | ||
| The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 | Phase 1 FPA008 Dose Escalation 4mg/kg | 0 | Participants | ||
| The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) | Phase 2 FPA008 Dose Expansion Cohort 2A | 8 | Participants | ||
| The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) | Phase 2 FPA008 Dose Expansion Cohort 2B | 8 | Participants | ||
| PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | Phase 1 FPA008 Dose Escalation 1mg/kg | 102 | Geometric Coefficient of Variation 10.2 | ug x day/mL | |
| PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | Phase 1 FPA008 Dose Escalation 2mg/kg | 283 | Geometric Coefficient of Variation 26.3 | ug x day/mL | |
| PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | Phase 1 FPA008 Dose Escalation 4mg/kg | 593 | Geometric Coefficient of Variation 31.3 | ug x day/mL | |
| PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | Phase 2 FPA008 Dose Expansion Cohort 2A | 660 | Geometric Coefficient of Variation 17.7 | ug x day/mL | |
| PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) | Phase 2 FPA008 Dose Expansion Cohort 2B | 593 | Geometric Coefficient of Variation 12.6 | ug x day/mL |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 FPA008 Dose Escalation 1mg/kg | 3 | |
| Overall Study | STARTED | Phase 1 FPA008 Dose Escalation 2mg/kg | 3 | |
| Overall Study | STARTED | Phase 1 FPA008 Dose Escalation 4mg/kg | 3 | |
| Overall Study | STARTED | Phase 2 FPA008 Dose Expansion Cohort 2A | 33 | |
| Overall Study | STARTED | Phase 2 FPA008 Dose Expansion Cohort 2B | 24 | |
| Overall Study | COMPLETED | Phase 1 FPA008 Dose Escalation 1mg/kg | 3 | |
| Overall Study | COMPLETED | Phase 1 FPA008 Dose Escalation 2mg/kg | 2 | |
| Overall Study | COMPLETED | Phase 1 FPA008 Dose Escalation 4mg/kg | 3 | |
| Overall Study | COMPLETED | Phase 2 FPA008 Dose Expansion Cohort 2A | 18 | |
| Overall Study | COMPLETED | Phase 2 FPA008 Dose Expansion Cohort 2B | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,155
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 | Phase 1 FPA008 Dose Escalation 1mg/kg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 FPA008 Dose Escalation 2mg/kg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 FPA008 Dose Escalation 4mg/kg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 FPA008 Dose Expansion Cohort 2A | 3 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 FPA008 Dose Expansion Cohort 2B | 0 | 24 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 FPA008 Dose Escalation 1mg/kg | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 FPA008 Dose Escalation 2mg/kg | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 FPA008 Dose Escalation 4mg/kg | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 2 FPA008 Dose Expansion Cohort 2A | 0 | 33 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 2 FPA008 Dose Expansion Cohort 2B | 1 | 24 |
1 to 10 of 1,155Source ClinicalTrials.gov
See all 1,155 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 FPA008 Dose Escalation 1mg/kg | 0 | 3 |
| Total, all-cause mortality | Phase 1 FPA008 Dose Escalation 2mg/kg | 0 | 3 |
| Total, all-cause mortality | Phase 1 FPA008 Dose Escalation 4mg/kg | 0 | 3 |
| Total, all-cause mortality | Phase 2 FPA008 Dose Expansion Cohort 2A | 1 | 32 |
| Total, all-cause mortality | Phase 2 FPA008 Dose Expansion Cohort 2B | 0 | 24 |
| Total, other adverse events | Phase 1 FPA008 Dose Escalation 1mg/kg | 3 | 3 |
| Total, other adverse events | Phase 1 FPA008 Dose Escalation 2mg/kg | 3 | 3 |
| Total, other adverse events | Phase 1 FPA008 Dose Escalation 4mg/kg | 3 | 3 |
| Total, other adverse events | Phase 2 FPA008 Dose Expansion Cohort 2A | 33 | 33 |
| Total, other adverse events | Phase 2 FPA008 Dose Expansion Cohort 2B | 24 | 24 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 2 FPA008 Dose Expansion Cohort 2A vs Phase 2 FPA008 Dose Expansion Cohort 2B: The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) |
Source 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/NCT02471716
GET https://conductscience.org/api/trials/v1/NCT02471716/results?page=2