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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Treatment

Active

18 and over

Pharmaceutical / Industry

47-01-001
NCT00705653

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Progen Pharmaceuticals Limited

Patient Enquiries, Progen Pharmaceuticals
		Email: patient.enquiries@progen.com.au

Trial Sites

U.S.A.

Illinois

Chicago

University of Chicago Cancer Research Center

Patient Enquiries, Progen Pharmaceuticals

Email: patient.enquiries@progen.com.au

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00705653
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.