105GM201: A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: TRC105, Bevacizumab Single arm study |
Drug: TRC105
10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
Other Names:
Drug: Bevacizumab
IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Median Overall Survival (OS) [6 Months]
Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial
Secondary Outcome Measures
- Median Duration That Patients Remained Progression Free on Study [Patients are scanned every 8 weeks for approximately 6 months]
The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.
- Number of Participants With Adverse Events [Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months]
Adverse event frequency per patient according to CTCAE version 4.0.
- Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)). [Patients are scanned every 8 weeks]
Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
-
Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma.
-
Patients with up to 3 prior recurrences are allowed.
-
Karnofsky performance status ≥ 70%.
-
Age ≥ 18 years old.
-
Normal organ function
Exclusion Criteria:
-
Patients who have had previous treatment with TRC105.
-
Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
-
Patients with cirrhosis, or active viral or nonviral hepatitis.
-
Patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia).
-
Patients who are currently receiving anticoagulation treatment
-
Patients unwilling or unable to comply with the protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Cincinnati | Cincinnati | Ohio | United States | 45267 |
2 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
3 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
4 | Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Tracon Pharmaceuticals Inc.
- The Cleveland Clinic
- Case Comprehensive Cancer Center
Investigators
- Study Director: Charles Theuer, MD PhD, Tracon Pharmaceuticals Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 105GM201/Case 1312
Study Results
Participant Flow
Recruitment Details | Patients were screened and enrolled at 4 sites |
---|---|
Pre-assignment Detail |
Arm/Group Title | Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) |
---|---|---|
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
Period Title: Overall Study | ||
STARTED | 16 | 6 |
COMPLETED | 16 | 6 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | TRC105, Bevacizumab | TRC105 | Total |
---|---|---|---|
Arm/Group Description | Single arm study TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks | Single arm TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle | Total of all reporting groups |
Overall Participants | 16 | 6 | 22 |
Age, Customized (years) [Median (Full Range) ] | |||
Age |
64.5
|
56.5
|
62
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
18.8%
|
3
50%
|
6
27.3%
|
Male |
13
81.3%
|
3
50%
|
16
72.7%
|
Screening Karnofsky Score (participants) [Number] | |||
Score = 60: requires occasional assistance |
1
6.3%
|
3
50%
|
4
18.2%
|
Score = 70: Can care for self; not normal activity |
4
25%
|
0
0%
|
4
18.2%
|
Score = 80: Normal activity with effort |
8
50%
|
2
33.3%
|
10
45.5%
|
Score = 90: Normal activities, minor symptoms. |
3
18.8%
|
1
16.7%
|
4
18.2%
|
Cancer Histology (Count of Participants) | |||
Glioblastoma |
15
93.8%
|
5
83.3%
|
20
90.9%
|
Giant Cell Glioblastoma |
1
6.3%
|
0
0%
|
1
4.5%
|
Astrocytoma |
0
0%
|
1
16.7%
|
1
4.5%
|
Number of Prior Regimens (prior regimens) [Median (Full Range) ] | |||
Median (Full Range) [prior regimens] |
2.5
|
3
|
3
|
Outcome Measures
Title | Median Overall Survival (OS) |
---|---|
Description | Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial |
Time Frame | 6 Months |
Outcome Measure Data
Analysis Population Description |
---|
Patients treated with TRC105 and bevacizumab who expired. Overall survival was not captured in the monotherapy portion of the study. |
Arm/Group Title | Carotuximab (TRC105), Bevacizumab |
---|---|
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks |
Measure Participants | 1 |
Median (95% Confidence Interval) [months] |
5.75
|
Title | Median Duration That Patients Remained Progression Free on Study |
---|---|
Description | The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. |
Time Frame | Patients are scanned every 8 weeks for approximately 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Patients with at least 1 on study scan were included in the efficacy population. The number of months that patients remained progression free was calculated for 5 evaluable monotherapy patients and 14 evaluable combination therapy patients. |
Arm/Group Title | Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) |
---|---|---|
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
Measure Participants | 14 | 5 |
Median (95% Confidence Interval) [months] |
1.81
|
1.38
|
Title | Number of Participants With Adverse Events |
---|---|
Description | Adverse event frequency per patient according to CTCAE version 4.0. |
Time Frame | Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received at least a portion of a dose of TRC105 and/or Bevacizumab |
Arm/Group Title | Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) |
---|---|---|
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every two weeks | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
Measure Participants | 16 | 6 |
Total SAEs |
6
37.5%
|
3
50%
|
TRC105 Related SAEs |
2
12.5%
|
0
0%
|
Title | Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)). |
---|---|
Description | Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. |
Time Frame | Patients are scanned every 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Nineteen patients had measurable disease at baseline and received at least one follow up scan and were evaluable for the secondary efficacy outcome measure of PFS by modified RANO criteria. None of the patients treated on this study had a reduction in tumor burden compared to baseline. |
Arm/Group Title | Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) Alone |
---|---|---|
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks | TRC105 alone 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
Measure Participants | 16 | 6 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
Time Frame | Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events (on average 4 months). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) | ||
Arm/Group Description | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle | ||
All Cause Mortality |
||||
Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/16 (6.3%) | 1/6 (16.7%) | ||
Serious Adverse Events |
||||
Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/16 (37.5%) | 3/6 (50%) | ||
Blood and lymphatic system disorders | ||||
Anemia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
General disorders | ||||
Disease Progression | 1/16 (6.3%) | 1 | 1/6 (16.7%) | 1 |
Peripheral Oedema | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Infections and infestations | ||||
Periorbital Cellulitis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Nervous system disorders | ||||
Aphasia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Cognitive Disorder | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Convulsion | 1/16 (6.3%) | 1 | 2/6 (33.3%) | 2 |
Mental Impairment | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Transient Ischemic Attack | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Hypoxia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Vascular disorders | ||||
Embolism | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Carotuximab (TRC105), Bevacizumab | Carotuximab (TRC105) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 16/16 (100%) | 6/6 (100%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 3/16 (18.8%) | 5 | 0/6 (0%) | 0 |
Lymphopenia | 2/16 (12.5%) | 5 | 0/6 (0%) | 0 |
Cardiac disorders | ||||
Tachycardia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Tachycardia | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Ear and labyrinth disorders | ||||
Tinnitus | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Endocrine disorders | ||||
Cushingoid | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Eye disorders | ||||
Optic Neuropathy | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Photophobia | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Visual Impairment | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Gastrointestinal disorders | ||||
Abdominal Distension | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Abdominal Pain | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Breath Odour | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Constipation | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
Defeacation Urgency | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Diarrhoea | 6/16 (37.5%) | 7 | 0/6 (0%) | 0 |
Dry Mouth | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Faecal Incontinence | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Gingival Pain | 1/16 (6.3%) | 2 | 0/6 (0%) | 0 |
Melaena | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Nausea | 2/16 (12.5%) | 2 | 1/6 (16.7%) | 2 |
Oral Pain | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Periodontitis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Stomatitis | 1/16 (6.3%) | 2 | 0/6 (0%) | 0 |
Tooth Impacted | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Toothache | 1/16 (6.3%) | 2 | 0/6 (0%) | 0 |
Vomiting | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
General disorders | ||||
Asthenia | 4/16 (25%) | 4 | 1/6 (16.7%) | 1 |
Chest Pain | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Chills | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Disease Progression | 1/16 (6.3%) | 1 | 1/6 (16.7%) | 1 |
Fatigue | 12/16 (75%) | 15 | 5/6 (83.3%) | 5 |
Feeling Hot | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Gait Disturbance | 6/16 (37.5%) | 8 | 0/6 (0%) | 0 |
Infusion Site Extravasation | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Localised Oedema | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Malaise | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Mucosal Inflammation | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Oedema Peripheral | 2/16 (12.5%) | 5 | 0/6 (0%) | 0 |
Pyrexia | 2/16 (12.5%) | 3 | 0/6 (0%) | 0 |
Infections and infestations | ||||
Periorbital Cellulitis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Sinusitis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Upper Respiratory Tract Infection | 4/16 (25%) | 4 | 0/6 (0%) | 0 |
Urinary Tract Infection | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Back Pain | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Contusion | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Fall | 4/16 (25%) | 6 | 0/6 (0%) | 0 |
Head Injury | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Infusion Related Reaction | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Limb Injury | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Investigations | ||||
Alanine Aminotransferase Increased | 2/16 (12.5%) | 2 | 1/6 (16.7%) | 1 |
Aspartate Aminotransferase Increased | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Cardiac Murmur | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Haemoglobin Decreased | 1/16 (6.3%) | 2 | 0/6 (0%) | 0 |
Lipase Increased | 1/16 (6.3%) | 2 | 0/6 (0%) | 0 |
Lymphocyte Count Decreased | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Platelet Count Decreased | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Weight Decreased | 2/16 (12.5%) | 4 | 0/6 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Decreased Appetite | 5/16 (31.3%) | 6 | 0/6 (0%) | 0 |
Hyperglycaemia | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Hypocalcaemia | 1/16 (6.3%) | 2 | 1/6 (16.7%) | 2 |
Hypokalaemia | 6/16 (37.5%) | 13 | 0/6 (0%) | 0 |
Hypophosphataemia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Vitamin D Deficiency | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Bursitis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Joint Stiffness | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Muscle Spasms | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Muscular Weakness | 3/16 (18.8%) | 5 | 2/6 (33.3%) | 3 |
Pain in extremity | 1/16 (6.3%) | 1 | 1/6 (16.7%) | 1 |
Nervous system disorders | ||||
Amnesia | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Aphasia | 2/16 (12.5%) | 4 | 4/6 (66.7%) | 5 |
Apraxia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Balance Disorder | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Clumsiness | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Cognitive Disorder | 5/16 (31.3%) | 6 | 2/6 (33.3%) | 3 |
Convulsion | 4/16 (25%) | 4 | 3/6 (50%) | 3 |
Coordination Abnormal | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Disturbance in Attention | 1/16 (6.3%) | 1 | 1/6 (16.7%) | 2 |
Dizziness | 4/16 (25%) | 5 | 0/6 (0%) | 0 |
Dysarthria | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Dysgeusia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Headache | 10/16 (62.5%) | 15 | 3/6 (50%) | 10 |
Hemianopia Homonymous | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Hypersomnia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Hypogeusia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Lethargy | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Loss of Consciousness | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Loss of Proprioception | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Memory Impairment | 2/16 (12.5%) | 2 | 1/6 (16.7%) | 1 |
Mental Impairment | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Migraine | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Neurological Symptom | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Neuropathy Peripheral | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Somnolence | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Transient Ischaemic Attack | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Tremor | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
VIIth Nerve Paralysis | 2/16 (12.5%) | 2 | 1/6 (16.7%) | 2 |
Psychiatric disorders | ||||
Anxiety | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Depression | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Disorientation | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Flat Affect | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Hallucination, visual | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Insomnia | 1/16 (6.3%) | 1 | 1/6 (16.7%) | 1 |
Renal and urinary disorders | ||||
Bilirubinuria | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Haematuria | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Micturition Urgency | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Pollakiuria | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Proteinuria | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Renal Failure Acute | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Renal cyst | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Urinary Incontinence | 2/16 (12.5%) | 2 | 1/6 (16.7%) | 1 |
Urinary Retention | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Dysphonia | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Dyspnoea | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
Hypoxia | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Nasal Congestion | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Nasal Discomfort | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Oropharyngeal Pain | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Pleural Effusion | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Respiratory Tract Congestion | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Rhinorrhoea | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Sinus Congestion | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Dermatitis Acneiform | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Ecchymosis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Onychoclasis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Petechiae | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Rash | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
Skin Irritation | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Vascular disorders | ||||
Embolism | 2/16 (12.5%) | 2 | 0/6 (0%) | 0 |
Epistaxis | 11/16 (68.8%) | 14 | 1/6 (16.7%) | 1 |
Flushing | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
Gingival Bleeding | 4/16 (25%) | 4 | 1/6 (16.7%) | 1 |
Haemoptysis | 1/16 (6.3%) | 1 | 0/6 (0%) | 0 |
Hypertension | 3/16 (18.8%) | 3 | 0/6 (0%) | 0 |
Telangiectasia | 0/16 (0%) | 0 | 1/6 (16.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Medical Monitor |
---|---|
Organization | TRACON Pharmaceuticals |
Phone | 8585500780 |
ctheuer@traconpharma.com |
- 105GM201/Case 1312