Trial Outcomes & Findings for TRC105 for Liver Cancer That Has Not Responded to Sorafenib (NCT NCT01375569)
NCT ID: NCT01375569
Last Updated: 2017-07-28
Results Overview
Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression 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 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
2 years
Results posted on
2017-07-28
Participant Flow
Participant milestones
| Measure |
TRC105 in Liver Cancer
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TRC105 for Liver Cancer That Has Not Responded to Sorafenib
Baseline characteristics by cohort
| Measure |
TRC105 in Liver Cancer
n=11 Participants
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.46 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTime to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression 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 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
TRC105 in Liver Cancer
n=11 Participants
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
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Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).
|
12 Weeks
Interval 4.0 to 32.0
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SECONDARY outcome
Timeframe: 25 months, 15 dayshere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
TRC105 in Liver Cancer
n=11 Participants
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
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Count of Participants With Adverse Events
|
11 Participants
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Adverse Events
TRC105 in Liver Cancer
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TRC105 in Liver Cancer
n=11 participants at risk
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
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Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Nervous system disorders
Encephalopathy
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Hepatobiliary disorders
Hepatic failure
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Number of events 2 • 25 months, 15 days
|
|
Cardiac disorders
Myocardial infarction
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
Other adverse events
| Measure |
TRC105 in Liver Cancer
n=11 participants at risk
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
36.4%
4/11 • Number of events 6 • 25 months, 15 days
|
|
Investigations
Alanine aminotransferase increased
|
54.5%
6/11 • Number of events 13 • 25 months, 15 days
|
|
Investigations
Alkaline phosphatase increased
|
72.7%
8/11 • Number of events 14 • 25 months, 15 days
|
|
Blood and lymphatic system disorders
Anemia
|
63.6%
7/11 • Number of events 23 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Number of events 3 • 25 months, 15 days
|
|
Gastrointestinal disorders
Ascites
|
18.2%
2/11 • Number of events 3 • 25 months, 15 days
|
|
Investigations
Aspartate aminotransferase increased
|
81.8%
9/11 • Number of events 27 • 25 months, 15 days
|
|
Investigations
Blood bilirubin increased
|
81.8%
9/11 • Number of events 19 • 25 months, 15 days
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Investigations
CPK increased
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Cardiac disorders
Chest pain - cardiac
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Number of events 3 • 25 months, 15 days
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 4 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
3/11 • Number of events 3 • 25 months, 15 days
|
|
General disorders
Edema limbs
|
54.5%
6/11 • Number of events 6 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
63.6%
7/11 • Number of events 11 • 25 months, 15 days
|
|
Eye disorders
Eye disorders - Other, specify (eye itchiness and redness)
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 5 • 25 months, 15 days
|
|
General disorders
Fever
|
18.2%
2/11 • Number of events 5 • 25 months, 15 days
|
|
Vascular disorders
Flushing
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Infections and infestations
Gallbladder infection
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Gingival pain
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Nervous system disorders
Headache
|
63.6%
7/11 • Number of events 15 • 25 months, 15 days
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 3 • 25 months, 15 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.2%
2/11 • Number of events 3 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
18.2%
2/11 • Number of events 4 • 25 months, 15 days
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.6%
7/11 • Number of events 20 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
63.6%
7/11 • Number of events 12 • 25 months, 15 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Infections and infestations
Infections and infestations - Other, specify (oral thrush)
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
General disorders
Infusion related reaction
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Investigations
Lymphocyte count decreased
|
54.5%
6/11 • Number of events 17 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 3 • 25 months, 15 days
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 3 • 25 months, 15 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
27.3%
3/11 • Number of events 5 • 25 months, 15 days
|
|
General disorders
Pain
|
36.4%
4/11 • Number of events 9 • 25 months, 15 days
|
|
Investigations
Platelet count decreased
|
45.5%
5/11 • Number of events 6 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify (hemoptysis)
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Investigations
Serum amylase increased
|
18.2%
2/11 • Number of events 6 • 25 months, 15 days
|
|
Cardiac disorders
Sinus tachycardia
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 3 • 25 months, 15 days
|
|
Investigations
Weight loss
|
9.1%
1/11 • Number of events 1 • 25 months, 15 days
|
|
Investigations
White blood cell decreased
|
18.2%
2/11 • Number of events 2 • 25 months, 15 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place