Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT00130442 |
Recruitment Status :
Completed
First Posted : August 15, 2005
Results First Posted : January 22, 2021
Last Update Posted : June 23, 2022
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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Safety population, defined as subjects who received at least one dose of study drug/s
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
Female |
15 23.1%
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27 40.9%
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42 32.1%
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Male |
50 76.9%
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39 59.1%
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89 67.9%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
Caucasian |
63 96.9%
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65 98.5%
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128 97.7%
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Other |
2 3.1%
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1 1.5%
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3 2.3%
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Height
Mean (Standard Deviation) Unit of measure: Cm |
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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 |
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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 |
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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.
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Name/Title: | Director of Regulatory Affairs and Clinical Development |
Organization: | Progen Pharmaceuticals Ltd |
Phone: | +61 (0)7 38423333 |
EMail: | darrynb@progen-pharma.com |
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 |