Expired Study
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Chicago, Illinois 60637


Purpose:

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 be established.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00705653


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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