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CompletedNCT02396511Updated Jun 11, 2019Results posted

TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

A Phase 2 interventional study of TRC105 and Bevacizumab in Choriocarcinoma, sponsored by Tracon Pharmaceuticals Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by Tracon Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

Read the detailed description

Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 is a monoclonal antibody to CD105, an angiogenic target highly expressed on the tumor vessels and the tumor cells in choriocarcinoma. Together, these antibodies may be efficacious in metastatic and refractory choriocarcinoma, a tumor type that is highly vascular and expresses endoglin. The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

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Conditions studied

  • Choriocarcinoma

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03

In context

Choriocarcinoma

23 studies on the registry are indexed under Choriocarcinoma; 3 are open to participants now.

This study's enrollment of 2 is below the median of 46 across 18 interventional studies indexed under Choriocarcinoma.

Browse Choriocarcinoma studies →

Lead sponsor

Tracon Pharmaceuticals Inc. is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Willingness and ability to consent for self to participate in study
  2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  3. Measurable disease by RECIST 1.1 and elevated serum β-hCG
  4. Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with TRC105
  2. Serious dose-limiting toxicity related to prior bevacizumab
  3. Current treatment on another therapeutic clinical trial
  4. Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
  5. Symptomatic pericardial or pleural effusions
  6. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
  7. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
  8. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
  9. Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days
  10. Known active viral or nonviral hepatitis
  11. Open wounds or unhealed fractures within 28 days of starting study treatment
  12. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
  13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    TRC105 and Bevacizumab

    TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

    Biological: TRC105 · Biological: Bevacizumab

Interventions

  • BiologicalTRC105

    weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops

    Also known as: Chimeric Antibody (TRC105) to CD105

  • BiologicalBevacizumab

    Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

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What researchers measure

Primary outcomes

  1. Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

    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.

    Time frame: Assessed every 8 weeks for up to 35 Months

  2. Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG

    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

    Time frame: Assessed every 8 weeks for up to 35 Months

Secondary outcomes

  1. Frequency and Severity of Adverse Events

    Adverse event frequency and severity according to CTCAE version 4.0.

    Time frame: Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.

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Results

Posted Jun 11, 2019

Participant flow

Participant flow — Overall Study
MilestoneTRC105 and Bevacizumab
Started2
Completed2
Not completed0

Outcome measures

PrimaryProgression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

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.

Time frame:
Assessed every 8 weeks for up to 35 Months
Reported as:
Mean · Months
Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma
MonthsTRC105 and Bevacizumab
Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma18 (1 to 35)
PrimaryObjective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG

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

Time frame:
Assessed every 8 weeks for up to 35 Months
Reported as:
Count of participants · Participants
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG
ParticipantsTRC105 and Bevacizumab
Response1
Progression1
SecondaryFrequency and Severity of Adverse Events

Adverse event frequency and severity according to CTCAE version 4.0.

Time frame:
Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.
Reported as:
Number · Events
Frequency and Severity of Adverse Events
EventsTRC105 and Bevacizumab
Total SAE's4
TRC105 Related SAEs3

Adverse events

Collected over Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, up to a maximum period of 35 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TRC105 and Bevacizumab0/2 (0%)2/2 (100%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventTRC105 and Bevacizumab
HeadacheNervous system disorders1/2
MigraineNervous system disorders1/2
Infusion Related ReactionInjury, poisoning and procedural complications1/2
MalaiseGeneral disorders1/2
Most frequent other events
Showing 10 of 33
Most frequent other events
EventTRC105 and Bevacizumab
FatigueGeneral disorders2/2
PyrexiaGeneral disorders1/2
HeadacheNervous system disorders1/2
HaemoptysisRespiratory, thoracic and mediastinal disorders1/2
HypomagnesaemiaMetabolism and nutrition disorders1/2
ArthralgiaMusculoskeletal and connective tissue disorders1/2
Mucosal InflammationGeneral disorders1/2
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders1/2
HypertensionVascular disorders1/2
MigraineNervous system disorders1/2

Baseline characteristics

Patients who enrolled in the trial who received at least a portion of a dose were included

Age, Continuous
Age, Continuous(Years)TRC105 and Bevacizumab
Mean39.5 (37 to 42)
Sex: Female, Male
Sex: Female, Male(Participants)TRC105 and Bevacizumab
Female2
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TRC105 and Bevacizumab
Hispanic or Latino1
Not Hispanic or Latino1
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TRC105 and Bevacizumab
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White1
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)TRC105 and Bevacizumab
United States2
Number of Prior Regimens
Number of Prior Regimens(prior regimens)TRC105 and Bevacizumab
Median7 (3 to 11)
08

Study locations

1 site
  • Dana-Farber Cancer Insititue
    Boston, Massachusetts 02215, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 17, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02396511
Lead sponsor
Tracon Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Jan 2015
Primary completion
Dec 2017
Completion
Dec 2017
Results posted
Jun 11, 2019
Last update
Jun 11, 2019

Study contacts

Charles Theuer, MD
study director · Medical Monitor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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