Trial Outcomes & Findings for TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma (NCT NCT02396511)

Last Updated: 2019-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Assessed every 8 weeks for up to 35 Months

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	TRC105 and Bevacizumab TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRC105 and Bevacizumab n=2 Participants TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Age, Continuous	39.5 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Number of Prior Regimens	7 prior regimens n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 8 weeks for up to 35 Months

Outcome measures

Outcome measures
Measure	TRC105 and Bevacizumab n=2 Participants TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma	18 Months Interval 1.0 to 35.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	TRC105 and Bevacizumab n=2 Participants TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG Response	1 Participants
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG Progression	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TRC105 and Bevacizumab n=2 Participants TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Frequency and Severity of Adverse Events Total SAE's	4 Events
Frequency and Severity of Adverse Events TRC105 Related SAEs	3 Events

Adverse Events

TRC105 and Bevacizumab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TRC105 and Bevacizumab n=2 participants at risk TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • 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.
Nervous system disorders Migraine	50.0% 1/2 • Number of events 1 • 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.
Injury, poisoning and procedural complications Infusion Related Reaction	50.0% 1/2 • Number of events 1 • 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.
General disorders Malaise	50.0% 1/2 • Number of events 1 • 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

Other adverse events
Measure	TRC105 and Bevacizumab n=2 participants at risk TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
General disorders Pyrexia	50.0% 1/2 • Number of events 1 • 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.
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • 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.
General disorders Fatigue	100.0% 2/2 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	50.0% 1/2 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypomagnesaemia	50.0% 1/2 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • 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.
General disorders Mucosal Inflammation	50.0% 1/2 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	50.0% 1/2 • Number of events 1 • 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.
Vascular disorders Hypertension	50.0% 1/2 • Number of events 1 • 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.
Nervous system disorders Migraine	50.0% 1/2 • Number of events 4 • 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.
Gastrointestinal disorders Gingival Bleeding	50.0% 1/2 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • Number of events 1 • 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.
Gastrointestinal disorders Glossodynia	50.0% 1/2 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • Number of events 2 • 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.
Psychiatric disorders Anxiety	50.0% 1/2 • Number of events 1 • 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.
Gastrointestinal disorders Gingival Pain	50.0% 1/2 • Number of events 4 • 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.
General disorders Chest discomfort	50.0% 1/2 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain upper	50.0% 1/2 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Dysphonia	50.0% 1/2 • Number of events 1 • 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.
Investigations Blood alkaline phosphatase increased	50.0% 1/2 • Number of events 1 • 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.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • Number of events 1 • 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.
Infections and infestations Urinary tract infection	50.0% 1/2 • Number of events 1 • 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.
Nervous system disorders Dizziness	50.0% 1/2 • Number of events 2 • 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.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Muscular Weakness	50.0% 1/2 • Number of events 1 • 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.
Infections and infestations Oral Viral Infection	50.0% 1/2 • Number of events 1 • 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.
Infections and infestations Gingival Infection	50.0% 1/2 • Number of events 4 • 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.
Musculoskeletal and connective tissue disorders Pain In Extremity	50.0% 1/2 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • 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.
Injury, poisoning and procedural complications Infusion related reaction	50.0% 1/2 • Number of events 2 • 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.
Eye disorders Periorbital oedema	50.0% 1/2 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	50.0% 1/2 • Number of events 1 • 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.
General disorders Malaise	50.0% 1/2 • Number of events 1 • 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.

Additional Information

Medical Monitor

TRACON Pharmaceuticals

Phone: 8585500780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60