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Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma (TAPPAS)

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ClinicalTrials.gov Identifier: NCT02979899
Recruitment Status : Completed
First Posted : December 2, 2016
Results First Posted : March 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Angiosarcoma
Interventions Biological: TRC105
Drug: Votrient
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Period Title: Overall Study
Started 64 64
Completed 64 64
Not Completed 0 0
Arm/Group Title TRC105 + Votrient Votrient Total
Hide Arm/Group Description

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Total of all reporting groups
Overall Number of Baseline Participants 64 64 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants 64 participants 128 participants
69
(32 to 82)
67
(25 to 84)
68
(25 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
Female
35
  54.7%
42
  65.6%
77
  60.2%
Male
29
  45.3%
22
  34.4%
51
  39.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
Hispanic or Latino
6
   9.4%
3
   4.7%
9
   7.0%
Not Hispanic or Latino
55
  85.9%
56
  87.5%
111
  86.7%
Not Reported
1
   1.6%
1
   1.6%
2
   1.6%
Unknown
2
   3.1%
4
   6.3%
6
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
United States 50 46 96
Poland 0 4 4
United Kingdom 8 9 17
France 6 5 11
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
ECOG Grade 0
30
  46.9%
27
  42.2%
57
  44.5%
ECOG Grade 1
32
  50.0%
36
  56.3%
68
  53.1%
Not Available
2
   3.1%
1
   1.6%
3
   2.3%
[1]
Measure Description:

0 = Fully active, able to carry on all pre-disease performance without restriction

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. = Dead
1.Primary Outcome
Title Progression Free Survival of Patients With Unresectable Angiosarcoma
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is defined as time from randomization to either first disease progression (per independent radiology review of images by RECIST 1.1) or death from any cause.
Time Frame from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut off date of interim analysis (25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients randomized onto study by cut off date of interim analysis
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description:

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Overall Number of Participants Analyzed 62 61
Mean (95% Confidence Interval)
Unit of Measure: months
PFS by RECIST 1.1
4.2
(2.8 to 8.3)
4.3 [1] 
(2.9 to NA)
PFS by Investigator Assessment
3.5
(2.6 to 5.5)
2.9
(2.6 to 4.1)
[1]
Confidence interval not estimable because not enough events to estimate a standard error
2.Secondary Outcome
Title Objective Response Rate of Patients With Unresectable Angiosarcoma
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Overall response rate is defined as the number of patients with a best response designation of complete response or partial response recorded between the date of randomization and the date of documented progression.
Time Frame from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut off date of interim analysis (25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients randomized onto study by cut off date of interim analysis
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description:

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Overall Number of Participants Analyzed 62 61
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.8%
8
  13.1%
3.Secondary Outcome
Title Overall Survival of Patients With Unresectable Angiosarcoma
Hide Description Overall survival is the number of death events at 25 months, including all on-study and off-study deaths (past post-treatment 28-day follow up visit)
Time Frame from beginning of study to cut off date of interim analysis (25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients randomized onto study by cut off date of interim analysis
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description:

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Overall Number of Participants Analyzed 62 61
Measure Type: Count of Participants
Unit of Measure: Participants
17
  27.4%
19
  31.1%
4.Secondary Outcome
Title To Characterize Patient Reported Outcomes Between the Two Arms of the Study
Hide Description Patient reported outcomes as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L) and the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 health scale is on a scale of 1 to 7, with 1 being poor health and 7 being excellent health. The EQ-5D-5L scale is on a scale of 0 to 100, with 0 being the worst health one can imagine, and 100 being the best health one can imagine.
Time Frame Screening and 9 weeks (Cycle 3 Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed the questionnaire during specified intervals listed below
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description:

Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily

TRC105: TRC105 antibody

Votrient: pazopanib

Standard dose votrient by mouth, once daily

Votrient: pazopanib

Overall Number of Participants Analyzed 64 62
Median (Full Range)
Unit of Measure: units on a scale
EORTC QLQ-C30 Health Score at Screening Number Analyzed 64 participants 62 participants
5
(1 to 7)
5
(1 to 7)
EQ-5D-5L Health Score at Screening Number Analyzed 59 participants 54 participants
75
(5 to 100)
75
(20 to 100)
EORTC QLQ-C30 Health Score at Cycle 3 Day 1 Number Analyzed 39 participants 38 participants
4
(1 to 6)
5
(1 to 6)
EQ-5D-5L Health Score at Cycle 3 Day 1 Number Analyzed 38 participants 38 participants
70
(20 to 100)
70
(20 to 97)
Time Frame Adverse events were collected over the entire duration of the study (a period of 26 months).
Adverse Event Reporting Description AEs were collected for each patient that received at least 1 dose of study drug from informed consent through 28 days following the last dose of study drug. Related AEs were followed until they resolved or became stable. All-Cause Mortality was monitored in all randomized participants as overall survival (OS) was a secondary endpoint of the study. OS was followed until death regardless of subsequent treatment. Patients were eligible for participation in the trial until they progressed.
 
Arm/Group Title TRC105 + Votrient Votrient
Hide Arm/Group Description All patients that received at least one dose of TRC105 in combination with pazopanib All patients that received at least one dose of pazopanib alone.
All-Cause Mortality
TRC105 + Votrient Votrient
Affected / at Risk (%) Affected / at Risk (%)
Total   23/64 (35.94%)   20/64 (31.25%) 
Hide Serious Adverse Events
TRC105 + Votrient Votrient
Affected / at Risk (%) Affected / at Risk (%)
Total   27/63 (42.86%)   12/57 (21.05%) 
Blood and lymphatic system disorders     
Platelet Disorder   0/63 (0.00%)  1/57 (1.75%) 
Anemia   1/63 (1.59%)  0/57 (0.00%) 
Cardiac disorders     
Myocardial Infarction   1/63 (1.59%)  0/57 (0.00%) 
Cardiac Failure   1/63 (1.59%)  0/57 (0.00%) 
Eye disorders     
Retinal Detachment   1/63 (1.59%)  0/57 (0.00%) 
Gastrointestinal disorders     
Pyrexia   1/63 (1.59%)  1/57 (1.75%) 
Upper Gastrointestinal Hemorrhage   1/63 (1.59%)  0/57 (0.00%) 
Proctalgia   1/63 (1.59%)  0/57 (0.00%) 
Pancreatitis   1/63 (1.59%)  0/57 (0.00%) 
Nausea   1/63 (1.59%)  0/57 (0.00%) 
Hematemesis   1/63 (1.59%)  0/57 (0.00%) 
Gastrointestinal Hemorrhage   1/63 (1.59%)  0/57 (0.00%) 
General disorders     
Disease Progression   4/63 (6.35%)  0/57 (0.00%) 
Fatigue   3/63 (4.76%)  0/57 (0.00%) 
Multi-Organ Failure   0/63 (0.00%)  1/57 (1.75%) 
Chest Pain   1/63 (1.59%)  0/57 (0.00%) 
Hepatobiliary disorders     
Acute Hepatic Failure   0/63 (0.00%)  1/57 (1.75%) 
Infections and infestations     
Wound infection   2/63 (3.17%)  1/57 (1.75%) 
Sepsis   0/63 (0.00%)  3/57 (5.26%) 
Urinary Tract Infection   1/63 (1.59%)  0/57 (0.00%) 
Osteomyelitis   1/63 (1.59%)  0/57 (0.00%) 
Meningitis Aseptic   1/63 (1.59%)  0/57 (0.00%) 
Influenza   1/63 (1.59%)  0/57 (0.00%) 
Bacteremia   1/63 (1.59%)  0/57 (0.00%) 
Injury, poisoning and procedural complications     
Subdural Hematoma   1/63 (1.59%)  0/57 (0.00%) 
Rib Fracture   1/63 (1.59%)  0/57 (0.00%) 
Infusion Related Reaction   1/63 (1.59%)  0/57 (0.00%) 
Fall   0/63 (0.00%)  1/57 (1.75%) 
Clavicle Fracture   1/63 (1.59%)  0/57 (0.00%) 
Investigations     
Aspartate Aminotransferase Increased   0/63 (0.00%)  1/57 (1.75%) 
Alanine Aminotransferase Increased   0/63 (0.00%)  1/57 (1.75%) 
Metabolism and nutrition disorders     
Tumor Lysis Syndrome   1/63 (1.59%)  0/57 (0.00%) 
Hyponatremia   1/63 (1.59%)  0/57 (0.00%) 
Failure To Thrive   0/63 (0.00%)  1/57 (1.75%) 
Dehydration   1/63 (1.59%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Chest Pain   0/63 (0.00%)  1/57 (1.75%) 
Nervous system disorders     
Headache   1/63 (1.59%)  0/57 (0.00%) 
Haemorrhage Intracranial   0/63 (0.00%)  1/57 (1.75%) 
Encephalopathy   1/63 (1.59%)  0/57 (0.00%) 
Tumor Hemorrhage   0/63 (0.00%)  1/57 (1.75%) 
Psychiatric disorders     
Mental Status Change   0/63 (0.00%)  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/63 (1.59%)  0/57 (0.00%) 
Respiratory Distress   1/63 (1.59%)  0/57 (0.00%) 
Pneumonitis   1/63 (1.59%)  0/57 (0.00%) 
Pleural Effusion   1/63 (1.59%)  0/57 (0.00%) 
Hypoxia   1/63 (1.59%)  0/57 (0.00%) 
Hydropneumothorax   0/63 (0.00%)  1/57 (1.75%) 
Dyspnea   1/63 (1.59%)  0/57 (0.00%) 
Vascular disorders     
Embolism   3/63 (4.76%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TRC105 + Votrient Votrient
Affected / at Risk (%) Affected / at Risk (%)
Total   63/63 (100.00%)   57/57 (100.00%) 
Blood and lymphatic system disorders     
Anemia   33/63 (52.38%)  5/57 (8.77%) 
Thrombocytopenia   3/63 (4.76%)  3/57 (5.26%) 
Cardiac disorders     
Sinus Tachycardia   3/63 (4.76%)  3/57 (5.26%) 
Bradycardia   4/63 (6.35%)  0/57 (0.00%) 
Tachycardia   3/63 (4.76%)  1/57 (1.75%) 
Endocrine disorders     
Hypothyroidism   11/63 (17.46%)  5/57 (8.77%) 
Hyperthyroidism   3/63 (4.76%)  1/57 (1.75%) 
Eye disorders     
Vision Blurred   6/63 (9.52%)  5/57 (8.77%) 
Lacrimation Increased   4/63 (6.35%)  0/57 (0.00%) 
Gastrointestinal disorders     
Diarrhea   38/63 (60.32%)  31/57 (54.39%) 
Nausea   34/63 (53.97%)  26/57 (45.61%) 
Vomiting   25/63 (39.68%)  13/57 (22.81%) 
Abdominal Pain   14/63 (22.22%)  10/57 (17.54%) 
Constipation   13/63 (20.63%)  9/57 (15.79%) 
Stomatitis   16/63 (25.40%)  5/57 (8.77%) 
Gingival Bleeding   17/63 (26.98%)  2/57 (3.51%) 
Dyspepsia   7/63 (11.11%)  5/57 (8.77%) 
Abdominal Pain Upper   6/63 (9.52%)  3/57 (5.26%) 
Dry Mouth   6/63 (9.52%)  3/57 (5.26%) 
Mouth Hemorrhage   7/63 (11.11%)  0/57 (0.00%) 
Oral Pain   6/63 (9.52%)  1/57 (1.75%) 
Gastrooesophageal Reflux Disease   3/63 (4.76%)  4/57 (7.02%) 
Flatulence   2/63 (3.17%)  5/57 (8.77%) 
Abdominal Distension   2/63 (3.17%)  3/57 (5.26%) 
Gingival Pain   4/63 (6.35%)  0/57 (0.00%) 
Hematemesis   4/63 (6.35%)  0/57 (0.00%) 
Oral Dysesthesia   3/63 (4.76%)  2/57 (3.51%) 
Hemorrhoids   3/63 (4.76%)  1/57 (1.75%) 
General disorders     
Fatigue   42/63 (66.67%)  33/57 (57.89%) 
Edema Peripheral   13/63 (20.63%)  6/57 (10.53%) 
Pyrexia   11/63 (17.46%)  4/57 (7.02%) 
Chills   10/63 (15.87%)  4/57 (7.02%) 
Mucosal Inflammation   7/63 (11.11%)  4/57 (7.02%) 
Asthenia   7/63 (11.11%)  2/57 (3.51%) 
Pain   5/63 (7.94%)  1/57 (1.75%) 
Chest Pain   4/63 (6.35%)  1/57 (1.75%) 
Disease Progression   4/63 (6.35%)  0/57 (0.00%) 
Non-Cardiac Chest Pain   3/63 (4.76%)  2/57 (3.51%) 
Facial Pain   3/63 (4.76%)  1/57 (1.75%) 
Hepatobiliary disorders     
Hyperbilirubinemia   2/63 (3.17%)  3/57 (5.26%) 
Infections and infestations     
Urinary Tract Infection   9/63 (14.29%)  2/57 (3.51%) 
Sepsis   0/63 (0.00%)  3/57 (5.26%) 
Injury, poisoning and procedural complications     
Infusion Related Reaction   8/63 (12.70%)  1/57 (1.75%) 
Fall   5/63 (7.94%)  3/57 (5.26%) 
Investigations     
Weight Decreased   23/63 (36.51%)  10/57 (17.54%) 
Aspartate Aminotransferase Increased   16/63 (25.40%)  14/57 (24.56%) 
Alanine Aminotransferase Increased   15/63 (23.81%)  12/57 (21.05%) 
Platelet Count Decreased   9/63 (14.29%)  7/57 (12.28%) 
Lipase Increased   9/63 (14.29%)  6/57 (10.53%) 
Blood Bilirubin Increased   6/63 (9.52%)  9/57 (15.79%) 
Blood Thyroid Stimulating Hormone Increased   6/63 (9.52%)  4/57 (7.02%) 
Neutrophil Count Decreased   5/63 (7.94%)  4/57 (7.02%) 
Blood Alkaline Phosphatase Increased   7/63 (11.11%)  1/57 (1.75%) 
Lymphocyte Count Decreased   7/63 (11.11%)  1/57 (1.75%) 
Blood Creatinine Increased   3/63 (4.76%)  4/57 (7.02%) 
White Blood Cell Count Decreased   4/63 (6.35%)  2/57 (3.51%) 
Blood Amylase Increased   3/63 (4.76%)  3/57 (5.26%) 
Metabolism and nutrition disorders     
Decreased Appetite   26/63 (41.27%)  19/57 (33.33%) 
Hypokalemia   14/63 (22.22%)  4/57 (7.02%) 
Dehydration   10/63 (15.87%)  3/57 (5.26%) 
Hypoalbuminaemia   9/63 (14.29%)  1/57 (1.75%) 
Hypomagnesaemia   7/63 (11.11%)  3/57 (5.26%) 
Hyponatraemia   6/63 (9.52%)  3/57 (5.26%) 
Hyperglycemia   5/63 (7.94%)  3/57 (5.26%) 
Hypocalcaemia   5/63 (7.94%)  0/57 (0.00%) 
Hypoxia   4/63 (6.35%)  1/57 (1.75%) 
Hyperkalemia   4/63 (6.35%)  0/57 (0.00%) 
Hypophosphatemia   3/63 (4.76%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Back Pain   13/63 (20.63%)  6/57 (10.53%) 
Myalgia   8/63 (12.70%)  6/57 (10.53%) 
Arthralgia   7/63 (11.11%)  5/57 (8.77%) 
Muscular Weakness   3/63 (4.76%)  6/57 (10.53%) 
Musculoskeletal Pain   5/63 (7.94%)  3/57 (5.26%) 
Muscle Spasms   5/63 (7.94%)  2/57 (3.51%) 
Pain In Extremity   2/63 (3.17%)  5/57 (8.77%) 
Musculoskeletal Chest Pain   4/63 (6.35%)  1/57 (1.75%) 
Pain In Jaw   4/63 (6.35%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor Pain   4/63 (6.35%)  4/57 (7.02%) 
Nervous system disorders     
Headache   42/63 (66.67%)  14/57 (24.56%) 
Dysgeusia   15/63 (23.81%)  15/57 (26.32%) 
Dizziness   7/63 (11.11%)  3/57 (5.26%) 
Migraine   4/63 (6.35%)  0/57 (0.00%) 
Psychiatric disorders     
Anxiety   6/63 (9.52%)  5/57 (8.77%) 
Insomnia   7/63 (11.11%)  3/57 (5.26%) 
Depression   3/63 (4.76%)  1/57 (1.75%) 
Renal and urinary disorders     
Proteinuria   3/63 (4.76%)  5/57 (8.77%) 
Hematuria   3/63 (4.76%)  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis   44/63 (69.84%)  4/57 (7.02%) 
Dyspnea   16/63 (25.40%)  6/57 (10.53%) 
Oropharyngeal Pain   5/63 (7.94%)  6/57 (10.53%) 
Cough   5/63 (7.94%)  5/57 (8.77%) 
Dysphonia   5/63 (7.94%)  4/57 (7.02%) 
Pleural effusion   5/63 (7.94%)  1/57 (1.75%) 
Nasal Congestion   4/63 (6.35%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia Syndrome   9/63 (14.29%)  9/57 (15.79%) 
Pruritus   4/63 (6.35%)  4/57 (7.02%) 
Dry Skin   3/63 (4.76%)  5/57 (8.77%) 
Erythema   4/63 (6.35%)  3/57 (5.26%) 
Rash   5/63 (7.94%)  1/57 (1.75%) 
Rash Maculo-Papular   5/63 (7.94%)  1/57 (1.75%) 
Alopecia   3/63 (4.76%)  3/57 (5.26%) 
Telangiectasia   5/63 (7.94%)  0/57 (0.00%) 
Skin Lesion   1/63 (1.59%)  3/57 (5.26%) 
Pain Of Skin   3/63 (4.76%)  1/57 (1.75%) 
Vascular disorders     
Hypertension   24/63 (38.10%)  32/57 (56.14%) 
Hypotension   11/63 (17.46%)  3/57 (5.26%) 
Flushing   11/63 (17.46%)  1/57 (1.75%) 
Embolism   6/63 (9.52%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Theuer, Medical Monitor
Organization: TRACON Pharmaceuticals Inc
Phone: 8585500780
EMail: ctheuer@traconpharma.com
Layout table for additonal information
Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02979899    
Other Study ID Numbers: 105SAR301
First Submitted: November 29, 2016
First Posted: December 2, 2016
Results First Submitted: February 27, 2020
Results First Posted: March 12, 2020
Last Update Posted: May 12, 2020