NCT01497925

Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

Phase 1 Trial of ADI PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC) and Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.

Conditions

• Solid Tumors
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ADI-PEG 20	Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.

Timeline

• Start date: 2011-09-06
• Primary completion: 2016-03-23
• Completion: 2018-08-31
• First posted: 2011-12-23
• Last updated: 2018-09-13

Locations

1 site across 1 country: United States