Trial · NCT02664961
Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)
NCT02664961, Phase 2, Terminated, Tracon Pharmaceuticals Inc.; results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN). Trials, record NCT02664961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02664961
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)
- NCT number
- NCT02664961
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Conditions
- Gestational Trophoblastic Neoplasia, Choriocarcinoma, Placental Site Trophoblastic Tumor, Epithelioid Trophoblastic Tumor
- Interventions
- TRC105, Bevacizumab
- First posted
- 2016-01-27
- Last updated
- 2019-07-23
- Results first posted
- 2019-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | 8 weeks | Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. |
| Secondary | Progression-Free Survival (PFS) | 8 weeks | Median Progression-Free Survival (PFS) via Serum hCG levels and response evaluation according to RECIST version 1.1 as a preliminary measure of the antitumor activity of TRC105. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. Patients must have screening (baseline) and at least one on study CT scan to be considered evaluable. |
| Secondary | Overall Response Rate on Bevacizumab Alone | 8 weeks | Overall Response Rate on bevacizumab alone according to RECIST 1.1 in combination with serum hCG levels. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. |
| Secondary | Maximum Plasma Concentration (Cmax) of TRC105. | cycle 2 day 1 (28 days after initiation of dosing) | Mean serum TRC105 concentrations were assessed at cycle 1 and cycle 2 on day 1, 8, 15, and 22 and on day 1 of every subsequent cycle using validated methods in order to determine the Cmax of TRC105 |
| Secondary | TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA). | 8 weeks | Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. Number of patients with positive APA titers on study will be reported. |
| Secondary | Frequency and Severity of Adverse Events | 20 months | Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03) |
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 | Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | 8 weeks | All patients who had a baseline scan and at least 1 on study assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | 8 weeks | Progression Free Survival | weeks | MEDIAN |
| SECONDARY | Overall Response Rate on Bevacizumab Alone | 8 weeks | No patients received bevacizumab alone. | ||
| SECONDARY | Maximum Plasma Concentration (Cmax) of TRC105. | cycle 2 day 1 (28 days after initiation of dosing) | ng/mL | MEAN | |
| SECONDARY | TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA). | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency and Severity of Adverse Events | 20 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | TRC105 and/or Bevacizumab | Number of patients with best response of PR | 0 | Participants | |
| Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | TRC105 and/or Bevacizumab | Number of patients with best response of SD | 0 | Participants | |
| Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | TRC105 and/or Bevacizumab | Number of patients with best response of PD | 3 | Participants | |
| Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab | TRC105 and/or Bevacizumab | Number of patients with best response of CR | 0 | Participants | |
| Progression-Free Survival (PFS) | TRC105 and/or Bevacizumab | 6 | Full Range 6 to 6 | weeks | |
| Maximum Plasma Concentration (Cmax) of TRC105. | TRC105 and/or Bevacizumab | 232500 | Full Range 199000 to 266000 | ng/mL | |
| TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA). | TRC105 and/or Bevacizumab | Number of patients with negative APA | 1 | Participants | |
| TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA). | TRC105 and/or Bevacizumab | Number of patients with positive APA | 2 | Participants | |
| Frequency and Severity of Adverse Events | TRC105 and/or Bevacizumab | Participants who experienced an SAE | 1 | Participants | |
| Frequency and Severity of Adverse Events | TRC105 and/or Bevacizumab | Participants who experienced a TRC105 related SAE | 0 | Participants |
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/or Bevacizumab | 3 | |
| Overall Study | COMPLETED | TRC105 and/or Bevacizumab | 3 | |
| Overall Study | NOT COMPLETED | TRC105 and/or Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events34
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 | TRC105 and/or Bevacizumab | 2 | 3 | 7 |
| other | Ascites | Gastrointestinal disorders | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
| other | Blood Amylase Increased | Investigations | TRC105 and/or Bevacizumab | 1 | 3 | 2 |
| other | Candiduria | Infections and infestations | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
| other | Constipation | Gastrointestinal disorders | TRC105 and/or Bevacizumab | 1 | 3 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
| other | Decreased Appetite | Metabolism and nutrition disorders | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
| other | Device Related Infection | Infections and infestations | TRC105 and/or Bevacizumab | 1 | 3 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | TRC105 and/or Bevacizumab | 1 | 3 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRC105 and/or Bevacizumab | 0 | 3 |
| Total, other adverse events | TRC105 and/or Bevacizumab | 3 | 3 |
| Total, serious adverse events | TRC105 and/or Bevacizumab | 1 | 3 |
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/NCT02664961
GET https://conductscience.org/api/trials/v1/NCT02664961/events?page=2