This phase I study aims to assess the safety and tolerability of a new drug - CGC-11047 -
and to establish what happens to the drug once inside the body. An escalating dose of
CGC-11047 will be investigated in this study and the maximum tolerated dose of the drug will
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 CGC-11047. CGC-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 CGC-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.
- non-hematological malignancy where standard therapeutic measures do not exist or no
- ECOG - 0-2.
- Life expectancy > 3 months.
- chemotherapy or radiotherapy within 4 weeks prior to entering the study.
- previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell
- 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