Trial Outcomes & Findings for TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma (NCT NCT01328574)
NCT ID: NCT01328574
Last Updated: 2017-01-13
Results Overview
Time interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
after 6 months on study
Results posted on
2017-01-13
Participant Flow
Participant milestones
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
|---|---|
|
Overall Study
Refused further treatment
|
1
|
Baseline Characteristics
TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
63.28 years
STANDARD_DEVIATION 6.64 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 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
|
13 participants
n=5 Participants
|
|
Median Age (Range)
|
67 years
n=5 Participants
|
|
Number of Previous Therapies for Metastatic Disease
1
|
3 participants
n=5 Participants
|
|
Number of Previous Therapies for Metastatic Disease
2
|
4 participants
n=5 Participants
|
|
Karnofsky Performance Status
60
|
1 participants
n=5 Participants
|
|
Karnofsky Performance Status
70
|
0 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
2 participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
10 participants
n=5 Participants
|
|
Primary Tumor Site
Bladder
|
11 participants
n=5 Participants
|
|
Primary Tumor Site
Upper urinary tract
|
2 participants
n=5 Participants
|
|
Metastatic Sites of Disease
Lung
|
7 participants
n=5 Participants
|
|
Metastatic Sites of Disease
Liver
|
2 participants
n=5 Participants
|
|
Metastatic Sites of Disease
Bone
|
4 participants
n=5 Participants
|
|
Metastatic Sites of Disease
Any visceral metastases
|
10 participants
n=5 Participants
|
|
Metastatic Sites of Disease
Lymph node only
|
3 participants
n=5 Participants
|
|
Number of Previous Therapies for Metastatic Disease
3
|
3 participants
n=5 Participants
|
|
Number of Previous Therapies for Metastatic Disease
4
|
2 participants
n=5 Participants
|
|
Number of Previous Therapies for Metastatic Disease
5
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 6 months on studyTime interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-
Outcome measures
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events.
|
|---|---|---|---|---|---|
|
Progression Free Survival
|
1.9 Months
Interval 1.8 to 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
12 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 25 monthsObjective response is defined as the number of participants who meet the criteria for a complete response (CR) or a partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events.
|
|---|---|---|---|---|---|
|
Objective Response
Complete response
|
0 participants
|
—
|
—
|
—
|
—
|
|
Objective Response
Partial response
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 25 monthsDate of on-study to the date of death from any cause or last follow up.
Outcome measures
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events.
|
|---|---|---|---|---|---|
|
Median Overall Survival
|
8.3 Months
Interval 3.3 to 17.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 monthsAdverse events by grade, (e.g. 1 is mild, 2 is moderate, 3 is severe and 4 is life threatening) related to TRC-105.
Outcome measures
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events.
|
TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4
n=13 Participants
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events.
|
|---|---|---|---|---|---|
|
Incidence of TRC-105-Related Adverse Events
Cough
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Anemia
|
6 participants
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Anorexia
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Edema (Limbs)
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Epistaxis
|
6 participants
|
6 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Fatigue
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Gum bleeding
|
4 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Headache
|
9 participants
|
8 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Hematuria
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Hypoalbuminemia
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Hypophosphatemia
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Increased Alanine Aminotransferase
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Infusion-Related Reaction
|
9 participants
|
5 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Maculopapular Rash
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Nasal Congestion
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Nausea
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Proteinuria
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Skin Infection
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Telangiectasia
|
6 participants
|
6 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Vomiting
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of TRC-105-Related Adverse Events
Xerostomia
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Single Arm-TRC105 in Urothelial Carcinoma
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 participants at risk
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
|---|---|
|
Infections and infestations
Bladder infection
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Death NOS
|
92.3%
12/13 • Number of events 12 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Single Arm-TRC105 in Urothelial Carcinoma
n=13 participants at risk
TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Number of events 2 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
3/13 • Number of events 3 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
2/13 • Number of events 6 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
61.5%
8/13 • Number of events 15 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • 24 months
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Cardiac disorders
Chest pain - cardiac
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Chills
|
15.4%
2/13 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • Number of events 4 • 24 months
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Dental caries
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 3 • 24 months
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
46.2%
6/13 • Number of events 7 • 24 months
|
|
General disorders
Facial pain
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Fever
|
38.5%
5/13 • Number of events 11 • 24 months
|
|
Eye disorders
Floaters
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Vascular disorders
Flushing
|
38.5%
5/13 • Number of events 5 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Genital edema
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Hallucinations
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Nervous system disorders
Headache
|
69.2%
9/13 • Number of events 14 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
15.4%
2/13 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 6 • 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.1%
3/13 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
2/13 • Number of events 3 • 24 months
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Infusion related reaction
|
15.4%
2/13 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
23.1%
3/13 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
30.8%
4/13 • Number of events 5 • 24 months
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Number of events 2 • 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
23.1%
3/13 • Number of events 3 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
7.7%
1/13 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 5 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place