A phase 2 study of the heparanase inhibitor P1-88 in patients with advanced melanoma

Lewis, Karl D., Robinson, William A., Millward, Michael J., Powell, Alex, Price, Timothy J., Thomson, Damien B., Walpole, Euan T., Haydon, Andrew M., Creese, Brian R., Roberts, Kaye L., Zalcberg, John R. and Gonzalex, Rene (2008) A phase 2 study of the heparanase inhibitor P1-88 in patients with advanced melanoma. Investigational New Drugs, 26 1: 89-94. doi:10.1007/s10637-007-9080-5

Author Lewis, Karl D.
Robinson, William A.
Millward, Michael J.
Powell, Alex
Price, Timothy J.
Thomson, Damien B.
Walpole, Euan T.
Haydon, Andrew M.
Creese, Brian R.
Roberts, Kaye L.
Zalcberg, John R.
Gonzalex, Rene
Title A phase 2 study of the heparanase inhibitor P1-88 in patients with advanced melanoma
Formatted title
A phase II study of the heparanase inhibitor P1-88 in patients with advanced melanoma
Journal name Investigational New Drugs   Check publisher's open access policy
ISSN 0167-6997
Publication date 2008-02-01
Year available 2008
Sub-type Article (original research)
DOI 10.1007/s10637-007-9080-5
Open Access Status
Volume 26
Issue 1
Start page 89
End page 94
Total pages 6
Editor E. K. Rowinsky
Place of publication United States
Publisher Springer New York LLC
Language eng
Subject 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
9201 Clinical Health (Organs, Diseases and Abnormal Conditions)
920102 Cancer and Related Disorders
Abstract Treatment options for advanced melanoma are limited. PI-88, a potent inhibitor of heparanase, demonstrates anitangiogenic properties and has shown activity against melanoma in phase I studies. This was an open-label, multicenter, phase II study of PI-88 in patients with advanced melanoma. Patients received a fixed-dose of 250 mg/day given subcutaneously for four consecutive days followed by three drug-free days per week in a 28-day cycle. A total of 44 patients were enrolled in the intent to treat population, with 59.1% having received previous therapy. The median time to progression and overall survival was 1.7 months and 9 months, respectively. Forty-one patients are included in the efficacy analysis. One (2.4%) patient achieved a partial response, six (14.6%) patients had stable disease as best response, and 30 (73.2%) had progressive disease. At the end of six cycles of treatment, three of the 41 evaluable patients had non-progressive disease. Treatment was generally well tolerated. Injection site bruising occurred in 45% of patients. Serious bleeding did occur in two patients and three patients developed a positive anti-platelet antibody test during the study. One of these four patients experienced an associated thrombosis. In patients with advanced melanoma, PI-88 demonstrates an overall survival and time to progression similar to standard chemotherapy. Although the current study did not meet the primary end-point of progression free survival of >/=20%, there is some evidence of activity and further investigation is warranted.
Keyword Melanoma
Heparanase inhibitor
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2009 Higher Education Research Data Collection
Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 49 times in Thomson Reuters Web of Science Article | Citations
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Created: Fri, 17 Apr 2009, 17:54:01 EST by Sarah Elliott on behalf of Royal Brisbane Clinical School