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

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

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.

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.

Inclusion Criteria:

• non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
• ECOG - 0-2.
• Life expectancy > 3 months.

Exclusion Criteria:

• chemotherapy or radiotherapy within 4 weeks prior to entering the study.
• previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
• primary brain tumors or active brain metastases
• history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality