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Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771810
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : June 7, 2013
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Tarix Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Thrombocytopenia
Neutropenia
Lymphopenia
Anemia
Interventions Drug: TXA127
Drug: Placebo
Enrollment 34
Recruitment Details Subjects were recruited from Feb2009 to Feb2012 across 10 oncology sites.
Pre-assignment Details  
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127 Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Period Title: Overall Study
Started 10 11 13
Completed 5 6 6
Not Completed 5 5 7
Reason Not Completed
Adverse Event             3             0             2
Lost to Follow-up             0             0             1
Physician Decision             1             2             2
Protocol Violation             0             1             1
Withdrawal by Subject             1             2             0
Other             0             0             1
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300ug/kg Total
Hide Arm/Group Description Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127 Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127 Total of all reporting groups
Overall Number of Baseline Participants 10 11 13 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 13 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  80.0%
9
  81.8%
10
  76.9%
27
  79.4%
>=65 years
2
  20.0%
2
  18.2%
3
  23.1%
7
  20.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 13 participants 34 participants
Female
10
 100.0%
11
 100.0%
13
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 13 participants 34 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
 100.0%
11
 100.0%
13
 100.0%
34
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 13 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  10.0%
0
   0.0%
1
   7.7%
2
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  18.2%
0
   0.0%
2
   5.9%
White
8
  80.0%
9
  81.8%
11
  84.6%
28
  82.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
0
   0.0%
1
   7.7%
2
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 13 participants 34 participants
10 11 13 34
1.Primary Outcome
Title Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Hide Description Mean percentage of cycles with platelet counts below 50,000/mm3
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the intention to treat population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 10 12
Mean (Full Range)
Unit of Measure: Percentage of cycles
20.0
(0 to 67)
11.7
(0 to 50)
21.5
(0 to 100)
2.Secondary Outcome
Title Subjects With Platelet Counts Below 50,000/mm3
Hide Description Number of subjects who experienced a platelet count below 50,000/mm3
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
5 4 6
3.Secondary Outcome
Title Treatment Cycles With Platelets Counts Below 25,000/mm3
Hide Description Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the intention to treat population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 10 12
Mean (Full Range)
Unit of Measure: Percentage of cycles
5.8
(0 to 33.3)
0
(0 to 0)
10.4
(0 to 83.3)
4.Secondary Outcome
Title Chemotherapy Dose Intensity and Dose Density
Hide Description Mean percentage of cycles where projected (target) chemotherapy dose was maintained
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the intention to treat population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 10 12
Mean (Full Range)
Unit of Measure: Percentage of cycles
Gemcitabine
67.6
(46.3 to 100.0)
86.5
(61.4 to 102.3)
71.7
(45.0 to 95.5)
Gemcitabine with Carboplatin or Cisplatin
76.7
(59.8 to 100.0)
88.7
(68.0 to 99.1)
79.5
(51.4 to 96.3)
5.Secondary Outcome
Title Lymphopenia as Determined by Lymphocyte Count
Hide Description Number of subjects with a treatment emergent adverse event of lymphopenia
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
1 0 0
6.Secondary Outcome
Title Neutropenia
Hide Description Number of subjects with a treatment emergent adverse event of neutropenia
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
7 5 8
7.Secondary Outcome
Title Anemia
Hide Description Number of subjects with a treatment emergent adverse event of anemia
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
2 4 5
8.Secondary Outcome
Title Mucositis
Hide Description Number of subjects with a treatment emergent adverse event of mucositis
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
2 0 1
9.Secondary Outcome
Title Alopecia
Hide Description Number of subjects with a treatment emergent adverse event of alopecia
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
1 2 3
10.Secondary Outcome
Title Rescue Treatment for Hematopoiesis and Mucositis
Hide Description

Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

  1. Transfusions
  2. Filgrastim or Pegfilgrastim
  3. Erythropoietin
  4. Palifermin
Time Frame During a maximum of six 3-week chemotherapy cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was the safety population.
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description:
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Overall Number of Participants Analyzed 10 11 13
Measure Type: Number
Unit of Measure: Participants
Hematopoiesis - Transfusions 2 4 2
Hematopoiesis - Filgrastim or Pegfilgrastim 4 2 5
Hematopoiesis - Erythropoietin 0 0 0
Mucositis - Palifermin 0 0 0
Time Frame February 2009 to May 2011
Adverse Event Reporting Description The assessment types were coded using MedDRA.
 
Arm/Group Title Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Hide Arm/Group Description Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127 Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
All-Cause Mortality
Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      1/11 (9.09%)      3/13 (23.08%)    
Gastrointestinal disorders       
Abdonminal pain lower  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Female genital tract fistula  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
General disorders       
Pyrexia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Psychiatric disorders       
Depressed mood  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Renal and urinary disorders       
Ureteric obstruction  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders       
Pleural effusion with dyspnoea  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Pleural effusion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders       
Hypertensive crisis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo TXA127 100 ug/kg TXA127 300 ug/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      11/11 (100.00%)      13/13 (100.00%)    
Blood and lymphatic system disorders       
Anaemia  1  2/10 (20.00%)  8 4/11 (36.36%)  16 5/13 (38.46%)  10
Bone marrow failure  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Leukocytosis  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Leukopenia  1  3/10 (30.00%)  13 3/11 (27.27%)  3 2/13 (15.38%)  3
Lymphopenia  1  1/10 (10.00%)  2 0/11 (0.00%)  0 0/13 (0.00%)  0
Neutropenia  1  7/10 (70.00%)  21 5/11 (45.45%)  13 8/13 (61.54%)  18
Neutrophil count decreased  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Thrombocytopenia  1  5/10 (50.00%)  10 5/11 (45.45%)  15 2/13 (15.38%)  2
Thrombocytosis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
White blood cell disorder  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Cardiac disorders       
Ascites  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Chest discomfort  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Dizziness  1  3/10 (30.00%)  5 3/11 (27.27%)  10 3/13 (23.08%)  11
Palpitations  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Sinus arrhythmia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Tachycardia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Ear and labyrinth disorders       
Ear pruritus  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Eye disorders       
Blepharospasm  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Vision blurred  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders       
Abdominal discomfort  1  0/10 (0.00%)  0 1/11 (9.09%)  2 2/13 (15.38%)  2
Abdominal distension  1  0/10 (0.00%)  0 1/11 (9.09%)  1 4/13 (30.77%)  7
Abdominal pain  1  5/10 (50.00%)  9 4/11 (36.36%)  4 1/13 (7.69%)  1
Abdominal pain lower  1  1/10 (10.00%)  1 1/11 (9.09%)  1 0/13 (0.00%)  0
Abdominal pain upper  1  1/10 (10.00%)  4 0/11 (0.00%)  0 0/13 (0.00%)  0
Abdominal tenderness  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Ageusia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Anorectal discomfort  1  0/10 (0.00%)  0 1/11 (9.09%)  1 1/13 (7.69%)  1
Ascites  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Constipation  1  8/10 (80.00%)  10 7/11 (63.64%)  12 5/13 (38.46%)  9
Diarrhoea  1  2/10 (20.00%)  4 1/11 (9.09%)  2 3/13 (23.08%)  3
Dry mouth  1  0/10 (0.00%)  0 1/11 (9.09%)  1 1/13 (7.69%)  1
Dry throat  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Dyspepsia  1  3/10 (30.00%)  3 4/11 (36.36%)  4 2/13 (15.38%)  2
Eructation  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Female genital tract fistula  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Flatulence  1  1/10 (10.00%)  1 1/11 (9.09%)  1 2/13 (15.38%)  2
Gastroenteritis viral  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Gastrooesophageal reflux disease  1  1/10 (10.00%)  1 1/11 (9.09%)  1 1/13 (7.69%)  1
Gingival pain  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Gingivitis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Glossodynia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Hiccups  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Mucous stools  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Nausea  1  7/10 (70.00%)  18 7/11 (63.64%)  17 9/13 (69.23%)  16
Oral pain  1  1/10 (10.00%)  1 2/11 (18.18%)  2 0/13 (0.00%)  0
Oropharyngeal pain  1  4/10 (40.00%)  4 1/11 (9.09%)  1 1/13 (7.69%)  1
Pharyngitis  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Rectal haemorrhage  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Regurgitation  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Stomatitis  1  2/10 (20.00%)  3 0/11 (0.00%)  0 1/13 (7.69%)  1
Tooth abscess  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Toothache  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Vomiting  1  6/10 (60.00%)  7 4/11 (36.36%)  9 5/13 (38.46%)  6
General disorders       
Adverse drug reaction  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Asthenia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 2/13 (15.38%)  5
Catheter site erythema  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Chest discomfort  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Chest pain  1  1/10 (10.00%)  2 0/11 (0.00%)  0 1/13 (7.69%)  1
Chills  1  1/10 (10.00%)  2 1/11 (9.09%)  2 1/13 (7.69%)  1
Device leakage  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Device malfunction  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Device related infection  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Discomfort  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Fatigue  1  8/10 (80.00%)  12 6/11 (54.55%)  17 7/13 (53.85%)  23
Feeling cold  1  0/10 (0.00%)  0 0/11 (0.00%)  0 3/13 (23.08%)  3
Feeling hot  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Flushing  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Hot flush  1  2/10 (20.00%)  2 0/11 (0.00%)  0 0/13 (0.00%)  0
Incision site pain  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Induration  1  1/10 (10.00%)  2 0/11 (0.00%)  0 0/13 (0.00%)  0
Influenza like illness  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Injection site mass  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Injection site pain  1  2/10 (20.00%)  6 2/11 (18.18%)  2 2/13 (15.38%)  2
Injection site rash  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Injection site discomfort  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Injection site haematoma  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Injection site haemorrhage  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Lethargy  1  2/10 (20.00%)  3 0/11 (0.00%)  0 0/13 (0.00%)  0
Malaise  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Night sweats  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Nodule  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Oedema Peripheral  1  0/10 (0.00%)  0 2/11 (18.18%)  2 2/13 (15.38%)  8
Pain  1  1/10 (10.00%)  1 2/11 (18.18%)  2 3/13 (23.08%)  14
Postoperative fever  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Pyrexia  1  2/10 (20.00%)  3 3/11 (27.27%)  8 2/13 (15.38%)  2
Swelling  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Hepatobiliary disorders       
Cholelithiasis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Hepatic pain  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Immune system disorders       
Hypersensitivity  1  5/10 (50.00%)  6 1/11 (9.09%)  1 2/13 (15.38%)  4
Infusion related reaction  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Seasonal allergy  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations       
Enterococcal infection  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Herpes zoster  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Infection  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Mastoiditis  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Pelvic infection  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications       
Post procedural haemorrhage  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Procedural pain  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  4
Procedural complication  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  16
Investigations       
Alanine aminotransferase increased  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  3
Blood glucose increased  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Blood urine present  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Haemoglobin decreased  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Neutrophil count decreased  1  1/10 (10.00%)  2 0/11 (0.00%)  0 0/13 (0.00%)  0
Transaminases abnormal  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  3
Weight decreased  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Weight increased  1  0/10 (0.00%)  0 1/11 (9.09%)  2 0/13 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/10 (0.00%)  0 3/11 (27.27%)  5 0/13 (0.00%)  0
Hyperglycemia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Hyperkalemia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Hypokalemia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Hypomagnesaemia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Thirst  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/10 (30.00%)  3 1/11 (9.09%)  1 1/13 (7.69%)  2
Back pain  1  2/10 (20.00%)  2 5/11 (45.45%)  7 5/13 (38.46%)  8
Bone lesion  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Bone pain  1  1/10 (10.00%)  1 0/11 (0.00%)  0 2/13 (15.38%)  2
Chills  1  1/10 (10.00%)  1 1/11 (9.09%)  3 1/13 (7.69%)  1
Facial asymmetry  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Fistula  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Groin Pain  1  1/10 (10.00%)  1 1/11 (9.09%)  1 1/13 (7.69%)  1
Joint swelling  1  0/10 (0.00%)  0 0/11 (0.00%)  0 2/13 (15.38%)  2
Muscle spasms  1  0/10 (0.00%)  0 0/11 (0.00%)  0 2/13 (15.38%)  2
Musculoskeletal pain  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Myalgia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 2/13 (15.38%)  2
Pain in extremity  1  2/10 (20.00%)  3 1/11 (9.09%)  1 2/13 (15.38%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders       
Dysgeusia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Dysphonia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Facial paresis  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Headache  1  7/10 (70.00%)  12 5/11 (45.45%)  8 5/13 (38.46%)  16
Hypoaesthesia  1  2/10 (20.00%)  3 0/11 (0.00%)  0 3/13 (23.08%)  5
Neuralgia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Neuropathy peripheral  1  1/10 (10.00%)  1 1/11 (9.09%)  1 1/13 (7.69%)  1
Paraesthesia  1  2/10 (20.00%)  2 1/11 (9.09%)  1 3/13 (23.08%)  3
Peripheral sensory neuropathy  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Sinus headache  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Somnolence  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Tinnitus  1  1/10 (10.00%)  1 2/11 (18.18%)  2 1/13 (7.69%)  1
Tremors  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  4
Urinary incontinence  1  1/10 (10.00%)  1 1/11 (9.09%)  1 0/13 (0.00%)  0
VIIth nerve paralysis  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Psychiatric disorders       
Anxiety  1  1/10 (10.00%)  1 1/11 (9.09%)  2 0/13 (0.00%)  0
Crying  1  1/10 (10.00%)  2 0/11 (0.00%)  0 0/13 (0.00%)  0
Depressed mood  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Depression  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Insomnia  1  2/10 (20.00%)  3 2/11 (18.18%)  3 0/13 (0.00%)  0
Nervousness  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Restlessness  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Sleep disorder  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders       
Bladder spasm  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Dysuria  1  3/10 (30.00%)  3 2/11 (18.18%)  3 1/13 (7.69%)  2
Enterovesical fistula  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Haematuria  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Hydronephrosis  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Stress urinary incontinence  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Ureteric obstruction  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Urinary tract infection  1  1/10 (10.00%)  3 1/11 (9.09%)  3 1/13 (7.69%)  1
Urogenital fistula  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Reproductive system and breast disorders       
Breast pain  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Dyspareunia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Menopausal symptoms  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Vaginal discharge  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Vaginal disorder  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Vaginal lesion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Cough  1  3/10 (30.00%)  6 0/11 (0.00%)  0 2/13 (15.38%)  2
Dyspnoea  1  2/10 (20.00%)  3 0/11 (0.00%)  0 5/13 (38.46%)  16
Dyspnoea exertional  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Musculoskeletal chest pain  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Nasal congestion  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Pleural effusion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 2/13 (15.38%)  2
Pleuritic pain  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Productive cough  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Rhinitis allergic  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Sinusitis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Upper respiratory tract infection  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Wheezing  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Paranasal sinus hypersecretion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  1/10 (10.00%)  1 2/11 (18.18%)  2 3/13 (23.08%)  3
Dry skin  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Erythema  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Hair disorder  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Onychalgia  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Pain of skin  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Pruritus  1  1/10 (10.00%)  1 1/11 (9.09%)  1 3/13 (23.08%)  5
Rash  1  1/10 (10.00%)  1 1/11 (9.09%)  1 5/13 (38.46%)  12
Rash generalised  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Skin exfoliation  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Skin induration  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Skin lesion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  2
Skin sensitisation  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Skin warm  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Swelling face  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders       
Epistaxis  1  3/10 (30.00%)  4 0/11 (0.00%)  0 0/13 (0.00%)  0
Haemorrhage  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Hypertension  1  1/10 (10.00%)  1 1/11 (9.09%)  3 0/13 (0.00%)  0
Hypertensive crisis  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/13 (0.00%)  0
Hypotension  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/13 (7.69%)  1
Injection site haemorrhage  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Feasibility considerations (e.g., slow patient enrollment and lower incidence of Grade 3-4 thrombocytopenia than planned) necessitated early termination of the study after 34 patients had been enrolled.
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
Layout table for Results Point of Contact information
Name/Title: Elizabeth Wagner
Organization: Tarix Pharmaceuticals
Phone: 6178760223
EMail: elizabeth.wagner@tarixpharma.com
Layout table for additonal information
Responsible Party: Tarix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00771810    
Other Study ID Numbers: TXA127-2007-002
First Submitted: October 9, 2008
First Posted: October 13, 2008
Results First Submitted: February 25, 2013
Results First Posted: June 7, 2013
Last Update Posted: November 13, 2017