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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Sponsor:
Cellxpert Biotechnology Corp.
Collaborator:
Medigen Biotechnology Corporation
Information provided by (Responsible Party):
Cellxpert Biotechnology Corp.
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | August 12, 2005 | |||||||||
First Posted Date ICMJE | August 15, 2005 | |||||||||
Results First Submitted Date ICMJE | October 19, 2020 | |||||||||
Results First Posted Date ICMJE | January 22, 2021 | |||||||||
Last Update Posted Date | June 23, 2022 | |||||||||
Study Start Date ICMJE | June 2005 | |||||||||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Non-progression Rate After Six 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) ] The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after six treatment cycles
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Original Primary Outcome Measures ICMJE |
The proportion of patients with objective response or stable disease (non-progression rate) after six treatment cycles | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma | |||||||||
Official Title ICMJE | A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma | |||||||||
Brief Summary | The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma. PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients. |
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Detailed Description | Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma. However, it is associated with low response rates (10-20%) and median survival of less than 12 months (6-11 months in most studies). PI-88 is an antiangiogenic and antimetastatic drug that has already shown some evidence of efficacy when used alone in an intermittent dosage regimen (4 consecutive days per week) in the treatment of patients with advanced melanoma. The FDA has designated PI-88 as an Orphan Drug for this indication, as well as for Stage III and high-risk stage II disease. The aim of this randomised pilot phase II trial is to determine whether PI-88 in combination with a standard regimen of dacarbazine (1000 mg/m2 every 3 weeks) should be considered for further investigation in a larger-scale trial. | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | |||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
134 | |||||||||
Original Enrollment ICMJE |
118 | |||||||||
Actual Study Completion Date ICMJE | October 2010 | |||||||||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Australia, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00130442 | |||||||||
Other Study ID Numbers ICMJE | PR88205 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Current Responsible Party | Cellxpert Biotechnology Corp. | |||||||||
Original Responsible Party | Not Provided | |||||||||
Current Study Sponsor ICMJE | Cellxpert Biotechnology Corp. | |||||||||
Original Study Sponsor ICMJE | Progen Industries Limited | |||||||||
Collaborators ICMJE | Medigen Biotechnology Corporation | |||||||||
Investigators ICMJE |
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PRS Account | Cellxpert Biotechnology Corp. | |||||||||
Verification Date | June 2022 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |