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Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors

Cancer Clinical Trial

Official title:
A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors

Clinical Trial Summary

This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.

Clinical Trial Description

This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00705653
Study type Interventional
Source Progen Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date March 2005
Completion date August 2009
View Details
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