Trial · NCT01975519
A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma
NCT01975519, Phase 1, Phase 2, Completed, Tracon Pharmaceuticals Inc.; results first posted 2020-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma. Trials, record NCT01975519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01975519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma
- NCT number
- NCT01975519
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Conditions
- Advanced Soft Tissue Sarcoma
- Interventions
- TRC105 and Pazopanib
- First posted
- 2013-11-04
- Last updated
- 2020-05-20
- Results first posted
- 2020-05-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) | 56 days | For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, febrile neutropenia (grade 4 neutropenia with fever \> 38.5 ºC both sustained over a 24 hour period), neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, grade \> 4 thrombocytopenia or grade ≥ 3 thrombocytopenia and grade ≥ 3 hemorrhage, or grade 3 or 4 nonhematologic toxicity with the following exceptions: nausea, vomiting, or diarrhea for \<48 hours, asymptomatic electrolyte abnormalities that are corrected to grade 1 or better in \< 72 hours, or headache lasting less than 48 hours. |
| Primary | Progression Free Survival of Patients With Advanced Soft Tissue Sarcoma (Phase 1 and 2) | from screening to either disease progression or death | Number of patients with progression free survival, as defined as time from screening to either first disease progression or death from any cause per RECIST version 1.1 |
| Primary | Objective Response Rate in a Cohort of Patients With Angiosarcoma | 1.5 years | The best response according to RECIST 1.1 for each patient in the phase 2 angiosarcoma cohort with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type |
| Secondary | Trough Concentrations of TRC105 (Phase 2) | 4, 6, 8, and 10 weeks | Trough serum TRC105 concentrations will be measured using validated ELISA methods. |
| Secondary | Number of Patients With and Without Development of Immunogenicity Antibodies (Phase 1 and 2) | 32 months | Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. |
| Secondary | Number of Patients With and Without Expression of Endoglin on Sarcoma Tissue (Phase 1 and 2) | 12 months | Expression will be determined by immunohistochemistry for each patient who received at least one dose of TRC105 |
| Secondary | Objective Response Rate in Patients With Advanced Soft Tissue Sarcoma by RECIST 1.1 | 12 months | The best response (CR, PR, SD or PD according to RECIST 1.1) for each patient (phase 1 and phase 2) with measurable disease who received at least one dose of TRC105 study drug |
| Secondary | Progression Free Survival in a Cohort of Patients With Angiosarcoma (Phase 2) | 26 months | Time from screening to either first disease progression or death from any cause per RECIST version 1.1 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) | 56 days | All phase 1b patients who received at least a portion of a dose of TRC105 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival of Patients With Advanced Soft Tissue Sarcoma (Phase 1 and 2) | from screening to either disease progression or death | All patients with scans completed at baseline and at least 1 time point on study. | months | MEAN |
| PRIMARY | Objective Response Rate in a Cohort of Patients With Angiosarcoma | 1.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Trough Concentrations of TRC105 (Phase 2) | 4, 6, 8, and 10 weeks | All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study | ug/mL | MEAN |
| SECONDARY | Number of Patients With and Without Development of Immunogenicity Antibodies (Phase 1 and 2) | 32 months | All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With and Without Expression of Endoglin on Sarcoma Tissue (Phase 1 and 2) | 12 months | All patients who received TRC105. Endoglin expression levels determined through archival tumor samples, which were drawn before dosing. Therefore dose levels combined. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate in Patients With Advanced Soft Tissue Sarcoma by RECIST 1.1 | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival in a Cohort of Patients With Angiosarcoma (Phase 2) | 26 months | months | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | TRC105 Plus Pazopanib | Patients with DLT at 8 mg/kg | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicity (DLT) | TRC105 Plus Pazopanib | Patients without DLT at 8 mg/kg | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicity (DLT) | TRC105 Plus Pazopanib | Patients with DLT at 10 mg/kg | 1 | Participants | |
| Number of Participants With Dose Limiting Toxicity (DLT) | TRC105 Plus Pazopanib | Patients without DLT at 10 mg/kg | 22 | Participants | |
| Progression Free Survival of Patients With Advanced Soft Tissue Sarcoma (Phase 1 and 2) | 8 mg/kg TRC105 + Pazopanib | 5.06 | 95% Confidence Interval 4.96 to NA | months | |
| Progression Free Survival of Patients With Advanced Soft Tissue Sarcoma (Phase 1 and 2) | 10 mg/kg TRC105 + Pazopanib | 3.45 | 95% Confidence Interval 2.56 to 3.85 | months | |
| Objective Response Rate in a Cohort of Patients With Angiosarcoma | 10 mg/kg TRC105 + Pazopanib With Angiosarcoma | Complete Response (CR) | 2 | Participants | |
| Objective Response Rate in a Cohort of Patients With Angiosarcoma | 10 mg/kg TRC105 + Pazopanib With Angiosarcoma | Partial Response (PR) | 0 | Participants | |
| Objective Response Rate in a Cohort of Patients With Angiosarcoma | 10 mg/kg TRC105 + Pazopanib With Angiosarcoma | Stable Disease (SD) | 3 | Participants | |
| Objective Response Rate in a Cohort of Patients With Angiosarcoma | 10 mg/kg TRC105 + Pazopanib With Angiosarcoma | Progressive Disease (PD) | 0 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 8 mg/kg TRC105 + Pazopanib | 3 | |
| Overall Study | STARTED | 10 mg/kg TRC105 + Pazopanib | 108 | |
| Overall Study | Phase 1b | 8 mg/kg TRC105 + Pazopanib | 3 | |
| Overall Study | Phase 1b | 10 mg/kg TRC105 + Pazopanib | 23 | |
| Overall Study | Phase 2a Soft Tissue Sarcoma | 8 mg/kg TRC105 + Pazopanib | 0 | |
| Overall Study | Phase 2a Soft Tissue Sarcoma | 10 mg/kg TRC105 + Pazopanib | 63 | |
| Overall Study | Phase 2a Angiosarcoma Cohort | 8 mg/kg TRC105 + Pazopanib | 0 | |
| Overall Study | Phase 2a Angiosarcoma Cohort | 10 mg/kg TRC105 + Pazopanib | 22 | |
| Overall Study | COMPLETED | 8 mg/kg TRC105 + Pazopanib | 3 | |
| Overall Study | COMPLETED | 10 mg/kg TRC105 + Pazopanib | 108 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events230
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 | Fatigue | General disorders | 8 mg/kg TRC105 + Pazopanib | 2 | 3 | |
| other | Fatigue | General disorders | 10 mg/kg TRC105 + Pazopanib | 80 | 106 | |
| other | Headache | Nervous system disorders | 8 mg/kg TRC105 + Pazopanib | 2 | 3 | |
| other | Headache | Nervous system disorders | 10 mg/kg TRC105 + Pazopanib | 75 | 106 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | 8 mg/kg TRC105 + Pazopanib | 3 | 3 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | 10 mg/kg TRC105 + Pazopanib | 73 | 106 | |
| other | Nausea | Gastrointestinal disorders | 8 mg/kg TRC105 + Pazopanib | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | 10 mg/kg TRC105 + Pazopanib | 66 | 106 | |
| other | Diarrhea | Gastrointestinal disorders | 8 mg/kg TRC105 + Pazopanib | 3 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | 10 mg/kg TRC105 + Pazopanib | 64 | 106 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 8 mg/kg TRC105 + Pazopanib | 0 | 3 |
| Total, all-cause mortality | 10 mg/kg TRC105 + Pazopanib | 9 | 106 |
| Total, other adverse events | 8 mg/kg TRC105 + Pazopanib | 3 | 3 |
| Total, other adverse events | 10 mg/kg TRC105 + Pazopanib | 106 | 106 |
| Total, serious adverse events | 8 mg/kg TRC105 + Pazopanib | 0 | 3 |
| Total, serious adverse events | 10 mg/kg TRC105 + Pazopanib | 9 | 106 |
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 |
|---|---|
| 8 mg/kg TRC105 + Pazopanib vs 10 mg/kg TRC105 + Pazopanib: deaths from any cause | Trial comparisons |
| 8 mg/kg TRC105 + Pazopanib vs 10 mg/kg TRC105 + Pazopanib: 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/NCT01975519
GET https://conductscience.org/api/trials/v1/NCT01975519/results?page=2