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Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma

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: NCT00130442
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : January 22, 2021
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
Medigen Biotechnology Corporation
Information provided by (Responsible Party):
Cellxpert Biotechnology Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: PI-88 and dacarbazine
Drug: dacarbazine or DTIC
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Period Title: Overall Study
Started 66 68
Completed 65 66
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             0             1
did not meet criteria             1             1
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone Total
Hide Arm/Group Description

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle

 Total of all reporting groups
Overall Number of Baseline Participants 65 66 131
Hide Baseline Analysis Population Description
Safety population, defined as subjects who received at least one dose of study drug/s
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 66 participants 131 participants
60.4  (13.26) 57.9  (13.07) 59.1  (13.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Female
15
  23.1%
27
  40.9%
42
  32.1%
Male
50
  76.9%
39
  59.1%
89
  67.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Caucasian
63
  96.9%
65
  98.5%
128
  97.7%
Other
2
   3.1%
1
   1.5%
3
   2.3%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 65 participants 66 participants 131 participants
174.0  (8.11) 171.2  (9.57) 172.6  (8.95)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 65 participants 66 participants 131 participants
85.11  (15.46) 81.54  (17.25) 83.31  (16.42)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants 66 participants 131 participants
28.15  (5.277) 27.64  (5.100) 27.89  (5.175)
ECOG status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 65 participants 66 participants 131 participants
0 44 45 89
1 21 21 42
[1]
Measure Description: The ECOG Performance Status is used to assess the functional status in terms of their ability to care for themselves, daily activity, and physical ability. ECOG uses 5 points score from grade 0 to grade 5, where lower grade indicates better independence.
1.Primary Outcome
Title Non-progression Rate After Six Cycles
Hide Description The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after six treatment cycles
Time Frame In week 3 of every second cycle (each cycle was 21 days) for all subjects enrolled, up to the end of cycle 6 (About 5 months after randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population consisted of all subjects randomised to treatment who received at least one dose of study medication, had a valid baseline measurement and who had returned for at least one visit post-baseline
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description:

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Overall Number of Participants Analyzed 65 65
Measure Type: Count of Participants
Unit of Measure: Participants
Non-progressed
13
  20.0%
18
  27.7%
Progressed
52
  80.0%
47
  72.3%
2.Secondary Outcome
Title Non-progression Rate
Hide Description The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after 2 or 4 treatment cycles
Time Frame In week 3 of every second cycle (each cycle was 21 days) for all subjects enrolled in cycle 2 and cycle 4.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, consisted of all subjects randomised to treatment who received at least one dose of study medication, had a valid baseline measurement and who had returned for at least one visit post-baseline.
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description:
PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Overall Number of Participants Analyzed 65 65
Measure Type: Count of Participants
Unit of Measure: Participants
End of cycle 2_Non-progressed
33
  50.8%
35
  53.8%
End of cycle 2_progressed
32
  49.2%
30
  46.2%
End of cycle 4_Non-progressed
24
  36.9%
31
  47.7%
End of cycle 4_progressed
41
  63.1%
33
  50.8%
3.Secondary Outcome
Title Time to Progression
Hide Description treatment was to continue until the subject experienced disease progression.
Time Frame At screening and in week 3 of every second cycle up to the end of cycle 6 and every third cycle after cycle 6 . Each cycle was 21 days.Assessed from date of randomization until the date of first documented progression, up to 50 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population consisted of all subjects randomised to treatment who received at least one dose of study medication, had a valid baseline measurement and who had returned for at least one visit post-baseline
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description:

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Overall Number of Participants Analyzed 65 65
Median (95% Confidence Interval)
Unit of Measure: days
66
(43 to 134)
82
(43 to 187)
4.Secondary Outcome
Title Duration of Response
Hide Description time from commencement to radiological evidence of progression
Time Frame At screening and in week 3 of every second cycle up to the end of cycle 6 and every third cycle after cycle 6. Each cycle was 21 days. Assessed from date of randomization until the date of first documented progression, up to 50 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population consisted of all subjects randomised to treatment who received at least one dose of study medication, had a valid baseline measurement and who had returned for at least one visit post-baseline
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description:

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: days
117.0  (65.73) 140.6  (89.38)
5.Secondary Outcome
Title Survival
Hide Description time to death and also at time-points 6 month and 12 months
Time Frame It was to assess time to death. The time frame is at least 6th month, 12th month and data was continuously collected till the end of the study, up to 50 months..
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population consisted of all subjects randomised to treatment who received at least one dose of study medication, had a valid baseline measurement and who had returned for at least one visit post-baseline
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description:

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
Overall Number of Participants Analyzed 65 65
Median (95% Confidence Interval)
Unit of Measure: days
304.00
(224.00 to 366.00)
416.00
(304.00 to 476.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Hide Arm/Group Description

PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion

dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
All-Cause Mortality
Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   20/65 (30.77%)   13/66 (19.70%) 
Blood and lymphatic system disorders     
Anaemia †  2/65 (3.08%)  0/66 (0.00%) 
Febrile neutropenia †  0/65 (0.00%)  1/66 (1.52%) 
Heparin-induced thrombocytopenia †  1/65 (1.54%)  0/66 (0.00%) 
Neutropenia †  0/65 (0.00%)  1/66 (1.52%) 
Thrombocytopenia †  4/65 (6.15%)  0/66 (0.00%) 
Cardiac disorders     
Myocardial infarction †  0/65 (0.00%)  1/66 (1.52%) 
Gastrointestinal disorders     
Abdominal pain †  1/65 (1.54%)  1/66 (1.52%) 
Haematemesis †  0/65 (0.00%)  1/66 (1.52%) 
Rectal haemorrhage †  1/65 (1.54%)  1/66 (1.52%) 
General disorders     
Pain †  1/65 (1.54%)  0/66 (0.00%) 
Pyrexia †  1/65 (1.54%)  1/66 (1.52%) 
Infections and infestations     
Cellulitis †  1/65 (1.54%)  0/66 (0.00%) 
Lower respiratory tract infection †  1/65 (1.54%)  1/66 (1.52%) 
Pneumonia †  0/65 (0.00%)  1/66 (1.52%) 
Respiratory tract infection †  1/65 (1.54%)  0/66 (0.00%) 
Sepsis †  0/65 (0.00%)  1/66 (1.52%) 
Subcutaneous abscess †  1/65 (1.54%)  0/66 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture †  0/65 (0.00%)  1/66 (1.52%) 
Overdose †  1/65 (1.54%)  0/66 (0.00%) 
Road traffic accident †  1/65 (1.54%)  0/66 (0.00%) 
Investigations     
Antibody test positive †  1/65 (1.54%)  0/66 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain †  1/65 (1.54%)  0/66 (0.00%) 
Muscular weakness †  1/65 (1.54%)  0/66 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion †  1/65 (1.54%)  0/66 (0.00%) 
Metastases to central nervous system †  0/65 (0.00%)  1/66 (1.52%) 
Nervous system disorders     
Cerebral haemorrhage †  1/65 (1.54%)  0/66 (0.00%) 
Cerebral infarction †  1/65 (1.54%)  0/66 (0.00%) 
Embolic stroke †  1/65 (1.54%)  0/66 (0.00%) 
Headache †  1/65 (1.54%)  1/66 (1.52%) 
Hemiparesis †  0/65 (0.00%)  1/66 (1.52%) 
Loss of consciousness †  0/65 (0.00%)  1/66 (1.52%) 
Syncope †  1/65 (1.54%)  0/66 (0.00%) 
Psychiatric disorders     
Anxiety †  0/65 (0.00%)  1/66 (1.52%) 
Renal and urinary disorders     
Haemorrhage urinary tract †  1/65 (1.54%)  0/66 (0.00%) 
Renal failure acute †  1/65 (1.54%)  0/66 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism †  0/65 (0.00%)  1/66 (1.52%) 
Wheezing †  1/65 (1.54%)  0/66 (0.00%) 
Skin and subcutaneous tissue disorders     
discolouration †  1/65 (1.54%)  0/66 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1- PI-88 Plus Dacarbazine Arm 2- Dacarbazine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   65/65 (100.00%)   61/66 (92.42%) 
Blood and lymphatic system disorders     
Neutropenia †  20/65 (30.77%)  18/66 (27.27%) 
Thrombocytopenia †  15/65 (23.08%)  8/66 (12.12%) 
Cardiac disorders     
Palpitations †  4/65 (6.15%)  1/66 (1.52%) 
Eye disorders     
Visual impairment †  4/65 (6.15%)  0/66 (0.00%) 
Gastrointestinal disorders     
Abdominal pain †  5/65 (7.69%)  9/66 (13.64%) 
Constipation †  25/65 (38.46%)  16/66 (24.24%) 
Diarrhoea †  14/65 (21.54%)  16/66 (24.24%) 
Dry mouth †  4/65 (6.15%)  1/66 (1.52%) 
Dyspepsia †  7/65 (10.77%)  7/66 (10.61%) 
Gastrooesophageal reflux disease †  5/65 (7.69%)  4/66 (6.06%) 
Nausea †  35/65 (53.85%)  39/66 (59.09%) 
Vomiting †  14/65 (21.54%)  13/66 (19.70%) 
General disorders     
Chest pain †  7/65 (10.77%)  8/66 (12.12%) 
Chills †  3/65 (4.62%)  7/66 (10.61%) 
Fatigue †  39/65 (60.00%)  39/66 (59.09%) 
Infusion site pain †  4/65 (6.15%)  8/66 (12.12%) 
Injection site haematoma †  30/65 (46.15%)  1/66 (1.52%) 
Inject site pain †  14/65 (21.54%)  2/66 (3.03%) 
Injection site reaction †  12/65 (18.46%)  0/66 (0.00%) 
Oedema peripheral †  6/65 (9.23%)  2/66 (3.03%) 
Pain †  4/65 (6.15%)  5/66 (7.58%) 
Pyrexia †  3/65 (4.62%)  8/66 (12.12%) 
Infections and infestations     
Lower respiratory track infection †  2/65 (3.08%)  5/66 (7.58%) 
Nasopharyngitis †  3/65 (4.62%)  7/66 (10.61%) 
Upper respiratory tract infection †  4/65 (6.15%)  6/66 (9.09%) 
Injury, poisoning and procedural complications     
Contusion †  13/65 (20.00%)  5/66 (7.58%) 
Investigations     
Alanine aminotransferase increased †  6/65 (9.23%)  0/66 (0.00%) 
Platelet count decreased †  4/65 (6.15%)  0/66 (0.00%) 
Weight decreased †  4/65 (6.15%)  3/66 (4.55%) 
Metabolism and nutrition disorders     
Decreased appetite †  14/65 (21.54%)  15/66 (22.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia †  8/65 (12.31%)  7/66 (10.61%) 
Back pain †  8/65 (12.31%)  10/66 (15.15%) 
Bone pain †  1/65 (1.54%)  5/66 (7.58%) 
Muscle spasms †  8/65 (12.31%)  2/66 (3.03%) 
Musculoskeletal pain †  3/65 (4.62%)  11/66 (16.67%) 
Pain in extremity †  7/65 (10.77%)  1/66 (1.52%) 
Nervous system disorders     
Burning sensation †  5/65 (7.69%)  0/66 (0.00%) 
Dizziness †  14/65 (21.54%)  13/66 (19.70%) 
Dysgeusia †  4/65 (6.15%)  4/66 (6.06%) 
Headache †  11/65 (16.92%)  16/66 (24.24%) 
Lethargy †  7/65 (10.77%)  3/66 (4.55%) 
Psychiatric disorders     
Anxiety †  4/65 (6.15%)  2/66 (3.03%) 
Depression †  2/65 (3.08%)  7/66 (10.61%) 
Insomnia †  16/65 (24.62%)  14/66 (21.21%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  14/65 (21.54%)  10/66 (15.15%) 
Dyspnoea †  11/65 (16.92%)  8/66 (12.12%) 
Oropharyngeal pain †  6/65 (9.23%)  3/66 (4.55%) 
Productive cough †  1/65 (1.54%)  4/66 (6.06%) 
Skin and subcutaneous tissue disorders     
Alopecia †  7/65 (10.77%)  2/66 (3.03%) 
Hyperhidrosis †  5/65 (7.69%)  4/66 (6.06%) 
Photosensitivity reaction †  3/65 (4.62%)  9/66 (13.64%) 
Pruritus †  7/65 (10.77%)  3/66 (4.55%) 
Rash †  7/65 (10.77%)  6/66 (9.09%) 
Vascular disorders     
Flushing †  6/65 (9.23%)  3/66 (4.55%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory Affairs and Clinical Development
Organization: Progen Pharmaceuticals Ltd
Phone: +61 (0)7 38423333
EMail: darrynb@progen-pharma.com
Layout table for additonal information
Responsible Party: Cellxpert Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT00130442    
Obsolete Identifiers: NCT00128648
Other Study ID Numbers: PR88205
First Submitted: August 12, 2005
First Posted: August 15, 2005
Results First Submitted: October 19, 2020
Results First Posted: January 22, 2021
Last Update Posted: June 23, 2022