Trial Outcomes & Findings for Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (NCT NCT01381861)
NCT ID: NCT01381861
Last Updated: 2019-03-05
Results Overview
Number of patients ongoing within the study who have not progressed after 6 months of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2019-03-05
Participant Flow
Patients were screened and enrolled at 7 US sites
Participant milestones
| Measure |
TRC105
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Baseline characteristics by cohort
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
59.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This population will include all patients enrolled in the study who receive at least 1 dose of TRC105 study medication and who undergo at least one on study efficacy assessment or expire due to progressive disease prior to the first efficacy assessment.
Number of patients ongoing within the study who have not progressed after 6 months of treatment
Outcome measures
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Progression-free Survival Rate After 6 Months of Treatment on Study
|
0 participants
|
PRIMARY outcome
Timeframe: Every 2 cyclesPopulation: This population will include all patients enrolled in the study who receive at least 1 dose of TRC105 study medication and who undergo at least one on study efficacy assessment or expire due to progressive disease prior to the first efficacy assessment.
Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Outcome measures
| Measure |
TRC105
n=22 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Proportion of Patients Who Have Objective Tumor Response
|
0 participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All patients who received at least a portion of a dose of TRC105.
Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
Outcome measures
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Adverse Events
Fatigue (Grade 3 Suspected Reaction)
|
1 Participants
|
|
Adverse Events
Anemia (Grade 3 Suspected Reaction)
|
4 Participants
|
|
Adverse Events
Headache (Grade 3 Suspected Reaction)
|
2 Participants
|
|
Adverse Events
Migraine (Grade 3 Suspected Reaction)
|
1 Participants
|
|
Adverse Events
Epistaxis (Grade 3 Suspected Reaction)
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 2 cyclesPopulation: All patients who received at least a portion of a dose of TRC105
CA-125 response rate by GCIG criteria
Outcome measures
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
CA-125 Response Rate
CA-125 Decrease
|
7 participants
|
|
CA-125 Response Rate
CA-125 Increase
|
16 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15Population: All patients who received at least a portion of a TRC105 dose
Median peak and trough concentration of TRC105 by ELISA in ug/mL
Outcome measures
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Serum Concentrations of TRC105
Median Trough Concentration Cycle 1 Day 15
|
47.4 ug/mL
Interval 0.0 to 93.1
|
|
Serum Concentrations of TRC105
Median Peak Concentration Cycle 1 Day 15
|
274.5 ug/mL
Interval 114.0 to 425.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients that received at least a portion of TRC105
TRC105 Anti-Drug Antibody (ADA) Immunogenicity by ELISA
Outcome measures
| Measure |
TRC105
n=17 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
TRC105 Immunogenicity
Patients with Positive Treatment Emergent ADA
|
7 Participants
|
|
TRC105 Immunogenicity
Patients with Negative Treatment Emergent ADA
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 days post last dose of TRC105Population: All patients who received at least a portion of a dose of TRC105.
Severity of adverse events by NCI CTCAE
Outcome measures
| Measure |
TRC105
n=23 Participants
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Severity of Adverse Events
Serious Adverse Events
|
6 participants
|
|
Severity of Adverse Events
TRC105 Related Serious Adverse Events
|
1 participants
|
|
Severity of Adverse Events
No Serious Adverse Events
|
16 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected
Median overall survival
Outcome measures
Outcome data not reported
Adverse Events
TRC105
Serious events: 6 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
TRC105
n=23 participants at risk
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Pyrexia
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Disease progression
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
Other adverse events
| Measure |
TRC105
n=23 participants at risk
Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
30.4%
7/23 • Number of events 7 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Eye disorders
Vision blurred
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.4%
4/23 • Number of events 4 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.1%
9/23 • Number of events 9 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Colonic obstruction
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Constipation
|
26.1%
6/23 • Number of events 6 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
47.8%
11/23 • Number of events 11 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Gingival pain
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23 • Number of events 8 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Toothache
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • Number of events 7 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Chest pain
|
17.4%
4/23 • Number of events 4 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Chills
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Disease progression
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Fatigue
|
52.2%
12/23 • Number of events 12 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Mucosal inflammation
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
General disorders
Pyrexia
|
21.7%
5/23 • Number of events 5 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
39.1%
9/23 • Number of events 9 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.1%
6/23 • Number of events 6 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.4%
4/23 • Number of events 4 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Nervous system disorders
Headache
|
56.5%
13/23 • Number of events 13 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Nervous system disorders
Migraine
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
5/23 • Number of events 5 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.4%
7/23 • Number of events 7 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
26.1%
6/23 • Number of events 6 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
1/23 • Number of events 1 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.4%
4/23 • Number of events 4 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
3/23 • Number of events 3 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Vascular disorders
Epistaxis
|
73.9%
17/23 • Number of events 17 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Vascular disorders
Flushing
|
26.1%
6/23 • Number of events 6 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Vascular disorders
Gingival bleeding
|
47.8%
11/23 • Number of events 11 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Vascular disorders
Hot flush
|
8.7%
2/23 • Number of events 2 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
|
Vascular disorders
Telangiectasia
|
34.8%
8/23 • Number of events 8 • Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60