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Trial record 4 of 526 for:    "Primary Peritoneal Carcinoma"

Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

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ClinicalTrials.gov Identifier: NCT01381861
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Ovarian Cancer
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Intervention Biological: Carotuximab (TRC105)
Enrollment 23
Recruitment Details Patients were screened and enrolled at 7 US sites
Pre-assignment Details  
Arm/Group Title TRC105
Hide Arm/Group Description 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
Period Title: Overall Study
Started 23
Completed 23
Not Completed 0
Arm/Group Title TRC105
Hide Arm/Group Description 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 Number of Baseline Participants 23
Hide Baseline Analysis Population Description
Total number of patients enrolled in the trial who received at least a portion of a dose of TRC105. Screen-failure patients are not included in the overall baseline analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  52.2%
>=65 years
11
  47.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
59.8
(26 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Progression-free Survival Rate After 6 Months of Treatment on Study
Hide Description Number of patients ongoing within the study who have not progressed after 6 months of treatment
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Proportion of Patients Who Have Objective Tumor Response
Hide Description Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Time Frame Every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title Adverse Events
Hide Description Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least a portion of a dose of TRC105.
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia (Grade 3 Suspected Reaction)
4
  17.4%
Fatigue (Grade 3 Suspected Reaction)
1
   4.3%
Headache (Grade 3 Suspected Reaction)
2
   8.7%
Migraine (Grade 3 Suspected Reaction)
1
   4.3%
Epistaxis (Grade 3 Suspected Reaction)
1
   4.3%
4.Secondary Outcome
Title CA-125 Response Rate
Hide Description CA-125 response rate by GCIG criteria
Time Frame Every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least a portion of a dose of TRC105
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
CA-125 Decrease 7
CA-125 Increase 16
5.Secondary Outcome
Title Serum Concentrations of TRC105
Hide Description Median peak and trough concentration of TRC105 by ELISA in ug/mL
Time Frame Cycle 1 Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least a portion of a TRC105 dose
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: ug/mL
Median Trough Concentration Cycle 1 Day 15
47.4
(0 to 93.1)
Median Peak Concentration Cycle 1 Day 15
274.5
(114 to 425)
6.Secondary Outcome
Title TRC105 Immunogenicity
Hide Description TRC105 Anti-Drug Antibody (ADA) Immunogenicity by ELISA
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received at least a portion of TRC105
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with Positive Treatment Emergent ADA
7
  41.2%
Patients with Negative Treatment Emergent ADA
10
  58.8%
7.Secondary Outcome
Title Severity of Adverse Events
Hide Description Severity of adverse events by NCI CTCAE
Time Frame 28 days post last dose of TRC105
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least a portion of a dose of TRC105.
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 6
TRC105 Related Serious Adverse Events 1
No Serious Adverse Events 16
8.Secondary Outcome
Title Overall Survival
Hide Description Median overall survival
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title TRC105
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, on average approximately 4 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TRC105
Hide Arm/Group Description 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
All-Cause Mortality
TRC105
Affected / at Risk (%)
Total   3/23 (13.04%)    
Show Serious Adverse Events Hide Serious Adverse Events
TRC105
Affected / at Risk (%) # Events
Total   6/23 (26.09%)    
General disorders   
Pyrexia  1  2/23 (8.70%)  2
Disease progression  1  3/23 (13.04%)  3
Metabolism and nutrition disorders   
Dehydration  1  1/23 (4.35%)  1
Nervous system disorders   
Headache  1  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/23 (4.35%)  1
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TRC105
Affected / at Risk (%) # Events
Total   23/23 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  7/23 (30.43%)  7
Cardiac disorders   
Atrial fibrillation  1  1/23 (4.35%)  1
Eye disorders   
Vision blurred  1  2/23 (8.70%)  2
Gastrointestinal disorders   
Abdominal distension  1  4/23 (17.39%)  4
Abdominal pain  1  9/23 (39.13%)  9
Colonic obstruction  1  1/23 (4.35%)  1
Constipation  1  6/23 (26.09%)  6
Diarrhoea  1  11/23 (47.83%)  11
Gingival pain  1  3/23 (13.04%)  3
Mouth ulceration  1  2/23 (8.70%)  2
Nausea  1  8/23 (34.78%)  8
Small intestinal obstruction  1  2/23 (8.70%)  2
Toothache  1  2/23 (8.70%)  2
Vomiting  1  7/23 (30.43%)  7
General disorders   
Chest pain  1  4/23 (17.39%)  4
Chills  1  2/23 (8.70%)  2
Disease progression  1  3/23 (13.04%)  3
Fatigue  1  12/23 (52.17%)  12
Mucosal inflammation  1  3/23 (13.04%)  3
Pyrexia  1  5/23 (21.74%)  5
Injury, poisoning and procedural complications   
Infusion related reaction  1  9/23 (39.13%)  9
Metabolism and nutrition disorders   
Decreased appetite  1  6/23 (26.09%)  6
Dehydration  1  3/23 (13.04%)  3
Hyperglycaemia  1  4/23 (17.39%)  4
Hypoalbuminaemia  1  3/23 (13.04%)  3
Hypocalcaemia  1  1/23 (4.35%)  1
Hypomagnesaemia  1  3/23 (13.04%)  3
Hyponatraemia  1  2/23 (8.70%)  2
Hypophosphataemia  1  1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/23 (13.04%)  3
Back pain  1  2/23 (8.70%)  2
Flank pain  1  1/23 (4.35%)  1
Musculoskeletal chest pain  1  1/23 (4.35%)  1
Myalgia  1  3/23 (13.04%)  3
Pain in extremity  1  2/23 (8.70%)  2
Nervous system disorders   
Headache  1  13/23 (56.52%)  13
Migraine  1  3/23 (13.04%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/23 (21.74%)  5
Dyspnoea  1  7/23 (30.43%)  7
Nasal congestion  1  6/23 (26.09%)  6
Pleural effusion  1  2/23 (8.70%)  2
Respiratory failure  1  1/23 (4.35%)  1
Skin and subcutaneous tissue disorders   
Erythema  1  4/23 (17.39%)  4
Pruritus  1  3/23 (13.04%)  3
Rash  1  2/23 (8.70%)  2
Skin hyperpigmentation  1  2/23 (8.70%)  2
Vascular disorders   
Epistaxis  1  17/23 (73.91%)  17
Flushing  1  6/23 (26.09%)  6
Gingival bleeding  1  11/23 (47.83%)  11
Hot flush  1  2/23 (8.70%)  2
Telangiectasia  1  8/23 (34.78%)  8
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Charles Theuer, Medical Monitor
Organization: TRACON Pharmaceuticals
Phone: 8585500780
Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01381861     History of Changes
Other Study ID Numbers: 105OC201
First Submitted: June 21, 2011
First Posted: June 27, 2011
Results First Submitted: November 15, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019