ChoriocarcinomaPhase 2NCT02396511

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

A Phase 2 study testing TRC105 and Bevacizumab in people with Choriocarcinoma, run by Tracon Pharmaceuticals Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Choriocarcinoma
What is being tested?: TRC105 and Bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Prior treatment with TRC105
Serious dose-limiting toxicity related to prior bevacizumab
Current treatment on another therapeutic clinical trial
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)
Symptomatic pericardial or pleural effusions
Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks

Show all 14Show fewer

Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days
Known active viral or nonviral hepatitis
Open wounds or unhealed fractures within 28 days of starting study treatment
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
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Dana-Farber Cancer Insititue
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

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.

Conditions: Choriocarcinoma
Being tested: TRC105, Bevacizumab
Medical subject headings: Choriocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRC105Biological
Also called Chimeric Antibody (TRC105) to CD105
weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops
BevacizumabBiological
Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

Study groups in NCT02396511
Study group	Role	What they receive
TRC105 and Bevacizumab	Experimental	TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion Receives: Biological: TRC105; Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed every 8 weeks for up to 35 Months
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
Measured: 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.
Measured: Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2017

First posted24 Mar 2015 (estimated)
Study startJan 2015
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ChoriocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02396511
Sponsor's protocol ID: 105CC201 & 105CC201B
Status last verified: May 2019
First submitted: 5 Mar 2015
Last updated: 11 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
RecruitingObservational study
Molecular Epidemiology of Pediatric Germ Cell Tumors
Germ Cell Tumor, Germinoma

All Choriocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma
ClinicalTrials.gov ID: NCT02396511
Acronym / sponsor ID: 105CC201 & 105CC201B
Conditions: Choriocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: Tracon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 11 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TRC105 and Bevacizumab	Experimental	Biological: TRC105, Biological: BevacizumabTRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

Prior treatment with TRC105
Serious dose-limiting toxicity related to prior bevacizumab
Current treatment on another therapeutic clinical trial
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)
Symptomatic pericardial or pleural effusions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRC105Also: Chimeric Antibody (TRC105) to CD105weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops	Biological	TRC105 and Bevacizumab
BevacizumabEvery 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops	Biological	TRC105 and Bevacizumab

Primary outcome

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma
Time frame: 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.
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG
Time frame: 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

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRC105 and Bevacizumab	2	2

Primary outcome: Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

Time frame: Assessed every 8 weeks for up to 35 Months. Mean (Full Range). Unit: Months

Measure	TRC105 and Bevacizumab n = 2
Value	18 (1 to 35)

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

Time frame: Assessed every 8 weeks for up to 35 Months. Count of participants. Unit: Participants

Measure	TRC105 and Bevacizumab n = 2
Response	1
Progression	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRC105 and Bevacizumab	2 of 2 (100%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Choriocarcinoma

RecruitingPhase 2
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
RecruitingObservational study
Molecular Epidemiology of Pediatric Germ Cell Tumors
Germ Cell Tumor, Germinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles Theuer, MD study director

Medical Monitor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TRC105 and Bevacizumab in people with Choriocarcinoma, run by Tracon Pharmaceuticals Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma (time frame: Assessed every 8 weeks for up to 35 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02396511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.