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A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

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ClinicalTrials.gov Identifier: NCT00878800
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : December 29, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Onxeo

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dose Escalation: Solid Tumors
MTD: Soft Tissue Sarcomas
Interventions Drug: PXD101
Drug: Doxorubicin
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75)
Hide Arm/Group Description PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Period Title: Overall Study
Started 3 7 9 6 16
Completed 0 [1] 0 [2] 0 [3] 0 [4] 0 [5]
Not Completed 3 7 9 6 16
Reason Not Completed
Adverse Event             0             0             2             0             1
Progressive disease             1             5             6             5             13
Withdrew consent             1             1             0             1             1
Death             0             0             1             0             0
Other             1             1             0             0             1
[1]
Mean number of cycles administered: 4.0
[2]
Mean number of cycles administered: 4.6
[3]
Mean number of cycles administered: 3.0
[4]
Mean number of cycles administered: 5.3
[5]
Mean number of cycles administered: 6.4
Arm/Group Title Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75) Total
Hide Arm/Group Description PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² Total of all reporting groups
Overall Number of Baseline Participants 3 7 9 6 16 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 9 participants 6 participants 16 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
5
  71.4%
8
  88.9%
4
  66.7%
11
  68.8%
31
  75.6%
>=65 years
0
   0.0%
2
  28.6%
1
  11.1%
2
  33.3%
5
  31.3%
10
  24.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 9 participants 6 participants 16 participants 41 participants
Female
0
   0.0%
4
  57.1%
4
  44.4%
0
   0.0%
7
  43.8%
15
  36.6%
Male
3
 100.0%
3
  42.9%
5
  55.6%
6
 100.0%
9
  56.3%
26
  63.4%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) PXD101
Hide Description Maximum Tolerated Dose (MTD) of PXD101treatment
Time Frame During Cohort 1 to 4, Cycle 1 only, up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Escalation
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: mg/m²
1000
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Doxorubicin
Hide Description Maximum Tolerated Dose (MTD) of doxorubicin
Time Frame During Cohort 1 to 4, Cycle 1 only, up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Escalation
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: mg/m2
75
3.Primary Outcome
Title Dose Limiting Toxicity (DLT)
Hide Description Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment
Time Frame Throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 25 16
Measure Type: Number
Unit of Measure: Dose limiting toxicity
0 0
4.Primary Outcome
Title Objective Response (CR and PR)
Hide Description Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.
Time Frame Throughout study, after every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 25 16
Measure Type: Number
Unit of Measure: percentage of participants
8 12.5
5.Secondary Outcome
Title Time to Response
Hide Description [Not Specified]
Time Frame Throughout study, after every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 25 16
Median (Full Range)
Unit of Measure: months
NA [1] 
(0.3 to NA)
NA [1] 
(1.2 to NA)
[1]
Median calculation not available due to only 2 responding patients
6.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame Throughout study, after every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only patients with response
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 2 2
Median (95% Confidence Interval)
Unit of Measure: Months
3.9
(3.1 to 4.8)
7.9
(4.4 to 11.3)
7.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame Throughout study, after every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only patients with disease progression.
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 18 15
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(3.0 to 5.6)
6.0
(1.6 to 9.7)
8.Secondary Outcome
Title Disease Control Rate (CR or PR or SD)
Hide Description The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria
Time Frame Throughout study, after every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.
Arm/Group Title Dose Escalation MTD Expansion
Hide Arm/Group Description:
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Number of Participants Analyzed 25 16
Measure Type: Number
Unit of Measure: percentage of participants
72.0 68.8
9.Secondary Outcome
Title Belinostat AUC (Time 0 to Last Measurement)
Hide Description Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2
Time Frame Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.
Arm/Group Title Day 4 - Belinostat 1000 mg/m² Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²
Hide Arm/Group Description:
Belinostat alone
Belinostat combined with doxorubicin
Overall Number of Participants Analyzed 21 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
23100
(35.4%)
22100
(43.2%)
10.Secondary Outcome
Title Belinostat Cmax
Hide Description Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2
Time Frame Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.
Arm/Group Title Day 4 - Belinostat 1000 mg/m² Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²
Hide Arm/Group Description:
Belinostat alone
Belinostat combined with doxorubicin
Overall Number of Participants Analyzed 21 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
41100
(35.0%)
37000
(59.1%)
11.Secondary Outcome
Title Belinostat t½
Hide Description Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2
Time Frame Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.
Arm/Group Title Day 4 - Belinostat 1000 mg/m² Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²
Hide Arm/Group Description:
Belinostat alone
Belinostat combined with doxorubicin
Overall Number of Participants Analyzed 18 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.48
(71.3%)
2.13
(119.4%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75)
Hide Arm/Group Description PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
All-Cause Mortality
Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   4/7 (57.14%)   5/9 (55.56%)   2/6 (33.33%)   10/16 (62.50%) 
Blood and lymphatic system disorders           
Anaemia † 1  1/3 (33.33%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Febrile neutropenia † 1  0/3 (0.00%)  2/7 (28.57%)  1/9 (11.11%)  0/6 (0.00%)  2/16 (12.50%) 
Neutropenia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
Cardiac disorders           
Myocardial infarction † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Myocardial ischaemia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders           
Vomiting † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Gastrointestinal haemorrhage † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Nausea † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
General disorders           
Thrombosis in device † 1  1/3 (33.33%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Disease progression † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Oedema peripheral † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Immune system disorders           
Hypersensitivity † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Infections and infestations           
Abdominal absecss † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Bacteriaemia † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Infection † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Device related infection † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/16 (0.00%) 
Neutropenic sepsis † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Pneumonia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  2/6 (33.33%)  1/16 (6.25%) 
Investigations           
Haemoglobin decreased † 1  1/3 (33.33%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Electrocardiogram QT prolonged † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Nervous system disorders           
Spinal cord compression † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders           
Skin swelling † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Vascular disorders           
Deep vein thrombosis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
Hypertension † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
†
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%
Cohort 1: BelDox IV (600/50) Cohort 2: BelDox IV (600/75) Cohort 3: BelDox IV (800/75) Cohort 4: BelDox IV (1000/75) MTD Expansion: BelDox IV (1000/75)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   7/7 (100.00%)   9/9 (100.00%)   6/6 (100.00%)   16/16 (100.00%) 
Blood and lymphatic system disorders           
Neutropenia † 1  1/3 (33.33%)  6/7 (85.71%)  2/9 (22.22%)  2/6 (33.33%)  11/16 (68.75%) 
Anaemia † 1  2/3 (66.67%)  2/7 (28.57%)  0/9 (0.00%)  1/6 (16.67%)  6/16 (37.50%) 
Febrile neutropenia † 1  0/3 (0.00%)  2/7 (28.57%)  1/9 (11.11%)  0/6 (0.00%)  3/16 (18.75%) 
Leukopenia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Cardiac disorders           
Arrhythmia † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/16 (6.25%) 
Palpitations † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Angina Pectoris † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Myocardial Infarction † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Myocardial Ischaemia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Ear and labyrinth disorders           
Tinnitus † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Eye disorders           
Dry Eye † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  2/16 (12.50%) 
Lacrimation Increased † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Conjunctivitis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Vision Blurred † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Gastrointestinal disorders           
Nausea † 1  2/3 (66.67%)  4/7 (57.14%)  6/9 (66.67%)  5/6 (83.33%)  14/16 (87.50%) 
Vomiting † 1  1/3 (33.33%)  4/7 (57.14%)  4/9 (44.44%)  3/6 (50.00%)  12/16 (75.00%) 
Constipation † 1  0/3 (0.00%)  2/7 (28.57%)  6/9 (66.67%)  3/6 (50.00%)  11/16 (68.75%) 
Diarrhoea † 1  0/3 (0.00%)  3/7 (42.86%)  3/9 (33.33%)  2/6 (33.33%)  7/16 (43.75%) 
Dyspepsia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  4/6 (66.67%)  3/16 (18.75%) 
Dry mouth † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  3/16 (18.75%) 
Stomatitis † 1  0/3 (0.00%)  2/7 (28.57%)  2/9 (22.22%)  1/6 (16.67%)  1/16 (6.25%) 
Abdominal pain † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  1/6 (16.67%)  1/16 (6.25%) 
Abdominal distention † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/16 (0.00%) 
Abdominal pain upper † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/16 (6.25%) 
Haemorrhoids † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Anal inflammation † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Anal pruritus † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Defaecation urgency † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Dysphagia † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Eructation † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Flatulence † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Gastrointestinal haemorrhage † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Gastrooesophagal reflux disease † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Palatal disorder † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Rectal haemorrhage † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Rectal tenesmus † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Salivary hypersecretion † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
General disorders           
Fatigue † 1  3/3 (100.00%)  7/7 (100.00%)  7/9 (77.78%)  6/6 (100.00%)  16/16 (100.00%) 
Mucosal inflammation † 1  0/3 (0.00%)  3/7 (42.86%)  2/9 (22.22%)  3/6 (50.00%)  12/16 (75.00%) 
Injection site reaction † 1  0/3 (0.00%)  0/7 (0.00%)  3/9 (33.33%)  3/6 (50.00%)  10/16 (62.50%) 
Pyrexia † 1  1/3 (33.33%)  1/7 (14.29%)  3/9 (33.33%)  1/6 (16.67%)  4/16 (25.00%) 
Pain † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  2/6 (33.33%)  4/16 (25.00%) 
Non-cardiac chest pain † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  3/16 (18.75%) 
Oedema peripheral † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  3/16 (18.75%) 
Chills † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  0/16 (0.00%) 
Influenza like illness † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/16 (12.50%) 
Chest pain † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
General physical health deterioration † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
Thrombosis in device † 1  1/3 (33.33%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Axillary pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Catheter site pain † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Catheter site swelling † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Chest discomfort † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Disease progression † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Extravasation † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Injection site pain † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Hepatobiliary disorders           
Hepatic Steatosis † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Immune system disorders           
Hypersensitivity † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/16 (12.50%) 
Infections and infestations           
Urinary Tract Infection † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  3/16 (18.75%) 
Device Related Infection † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  1/16 (6.25%) 
Pneumonia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  2/6 (33.33%)  1/16 (6.25%) 
Gastroenteritis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/16 (6.25%) 
Infection † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Lung Infection † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  0/16 (0.00%) 
Oral Candidiasis † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Abdominal Abscess † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Bacteraemia † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Bronchitis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Cystitis † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Herpes Zoster † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Neutropenic Sepsis † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Subcutaneous Abscess † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Tinea Pedis † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Wound Infection † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Injury, poisoning and procedural complications           
Fall † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Open wound † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Investigations           
Neutrophil Count † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  4/6 (66.67%)  0/16 (0.00%) 
Neutrophil Count Decreased † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  3/16 (18.75%) 
Blood Bilirubin † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/16 (6.25%) 
Blood Potassium Decreased † 1  1/3 (33.33%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Blood Sodium Decreased † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Electrocardiogram Qt Prolonged † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Haemoglobin † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Haemoglobin Decreased † 1  1/3 (33.33%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Platelet Count Decreased † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/16 (6.25%) 
Weight Decreased † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Activated Partial Thromboplastin Time Prolonged † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Blood Potassium † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Blood Pressure Increased † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
International Normalised Ratio Increased † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Troponin † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  0/3 (0.00%)  2/7 (28.57%)  3/9 (33.33%)  3/6 (50.00%)  14/16 (87.50%) 
Hypokalaemia † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  3/16 (18.75%) 
Hyponatraemia † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Hypocalcaemia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Hypomagnesaemia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders           
Muscle Spasms † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/16 (18.75%) 
Arthralgia † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Back Pain † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  0/16 (0.00%) 
Neck Pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/16 (6.25%) 
Pain In Extremity † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Arthropathy † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Intervertebral Disc Protrusion † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Muscle Rigidity † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Musculoskeletal Chest Pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Musculoskeletal Pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Myalgia † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Soft Tissue Disorder † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cancer Pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Tumour Pain † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Nervous system disorders           
Headache † 1  0/3 (0.00%)  3/7 (42.86%)  3/9 (33.33%)  2/6 (33.33%)  10/16 (62.50%) 
Dizziness † 1  0/3 (0.00%)  1/7 (14.29%)  1/9 (11.11%)  2/6 (33.33%)  0/16 (0.00%) 
Cerebral Haematoma † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Dysgeusia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Neuropathy Peripheral † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Peripheral Motor Neuropathy † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Peripheral Sensory Neuropathy † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Spinal Cord Compression † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Psychiatric disorders           
Insomnia † 1  0/3 (0.00%)  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  1/16 (6.25%) 
Anxiety † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Restlessness † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Renal and urinary disorders           
Urinary Retention † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Bladder Pain † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Bladder Spasm † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Haematuria † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Micturition Urgency † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Pollakiuria † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Renal Pain † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Reproductive system and breast disorders           
Erectile Dysfunction † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Vaginal Haemorrhage † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea † 1  2/3 (66.67%)  1/7 (14.29%)  4/9 (44.44%)  4/6 (66.67%)  11/16 (68.75%) 
Cough † 1  1/3 (33.33%)  0/7 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  3/16 (18.75%) 
Rhinitis Allergic † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  0/16 (0.00%) 
Epistaxis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/16 (6.25%) 
Pulmonary Embolism † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
Dysphonia † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Oropharyngeal Pain † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Pulmonary Haemorrhage † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Yawning † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia † 1  1/3 (33.33%)  4/7 (57.14%)  3/9 (33.33%)  5/6 (83.33%)  13/16 (81.25%) 
Rash † 1  0/3 (0.00%)  0/7 (0.00%)  3/9 (33.33%)  1/6 (16.67%)  3/16 (18.75%) 
Dry skin † 1  0/3 (0.00%)  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Dermatitis allergic † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Hair colour changes † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Intertrigo † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Nail disorder † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Night sweats † 1  1/3 (33.33%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Pruritus † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Rash papular † 1  0/3 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Skin swelling † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Skin ulcer † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Vitiligo † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/16 (0.00%) 
Social circumstances           
Abstains From Alcohol † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
Vascular disorders           
Hot Flush † 1  0/3 (0.00%)  0/7 (0.00%)  2/9 (22.22%)  2/6 (33.33%)  0/16 (0.00%) 
Flushing † 1  0/3 (0.00%)  2/7 (28.57%)  1/9 (11.11%)  0/6 (0.00%)  0/16 (0.00%) 
Deep Vein Thrombosis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/16 (12.50%) 
Hypertension † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/16 (6.25%) 
Hypotension † 1  0/3 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/16 (0.00%) 
Phlebitis † 1  0/3 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/16 (6.25%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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: PRS Administrator Gunilla Emanuelson
Organization: Topotarget A/S
Phone: +45 39 17 83 92
EMail: enquiries@topotarget.com
Layout table for additonal information
Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT00878800    
Other Study ID Numbers: PXD101-CLN-14
First Submitted: April 7, 2009
First Posted: April 9, 2009
Results First Submitted: July 7, 2014
Results First Posted: December 29, 2014
Last Update Posted: July 28, 2015