Trial · NCT02396511
TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma
NCT02396511, Phase 2, Completed, Tracon Pharmaceuticals Inc.; results first posted 2019-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma. Trials, record NCT02396511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02396511
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma
- NCT number
- NCT02396511
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Conditions
- Choriocarcinoma
- Interventions
- TRC105, Bevacizumab
- First posted
- 2015-03-24
- Last updated
- 2019-06-11
- Results first posted
- 2019-06-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma | Assessed every 8 weeks for up to 35 Months | Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma determined according to RECIST 1.1 including measurement of serum β- hCG. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. A 5 mm absolute increase is also required to guard against over calling PD when the total sum is very small. |
| Primary | Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG | Assessed every 8 weeks for up to 35 Months | To determine the Objective Response Rate of two patients with metastatic and refractory choriocarcinoma by RECIST 1.1 including measurement of serum β- hCG. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) categorizes response as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Frequency and Severity of Adverse Events | Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months. | Adverse event frequency and severity according to CTCAE version 4.0. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma | Assessed every 8 weeks for up to 35 Months | Months | MEAN | |
| PRIMARY | Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG | Assessed every 8 weeks for up to 35 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency and Severity of Adverse Events | Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months. | Events | NUMBER |
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 |
|---|---|---|---|---|---|
| Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma | TRC105 and Bevacizumab | 18 | Full Range 1 to 35 | Months | |
| Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG | TRC105 and Bevacizumab | Response | 1 | Participants | |
| Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG | TRC105 and Bevacizumab | Progression | 1 | Participants | |
| Frequency and Severity of Adverse Events | TRC105 and Bevacizumab | Total SAE's | 4 | Events | |
| Frequency and Severity of Adverse Events | TRC105 and Bevacizumab | TRC105 Related SAEs | 3 | Events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TRC105 and Bevacizumab | 2 | |
| Overall Study | COMPLETED | TRC105 and Bevacizumab | 2 | |
| Overall Study | NOT COMPLETED | TRC105 and Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events37
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 | Pyrexia | General disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Headache | Nervous system disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Fatigue | General disorders | TRC105 and Bevacizumab | 2 | 2 | 4 |
| other | Haemoptysis | Respiratory, thoracic and mediastinal disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Mucosal Inflammation | General disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Hypertension | Vascular disorders | TRC105 and Bevacizumab | 1 | 2 | 1 |
| other | Migraine | Nervous system disorders | TRC105 and Bevacizumab | 1 | 2 | 4 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRC105 and Bevacizumab | 0 | 2 |
| Total, other adverse events | TRC105 and Bevacizumab | 2 | 2 |
| Total, serious adverse events | TRC105 and Bevacizumab | 2 | 2 |
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/NCT02396511
GET https://conductscience.org/api/trials/v1/NCT02396511/events?page=2