NCT01665183

Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy of this combination will be explored in patients with cancers that require arginine.

Conditions

• Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ADI-PEG 20

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-08-15
• Last updated: 2016-02-25

Locations

2 sites across 2 countries: United States, Taiwan