Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00705653|
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : February 27, 2012
Last Update Posted : March 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: PG-11047||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors|
|Study Start Date :||March 2005|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).
- Maximum Tolerated Dose (MTD) [ Time Frame: The MTD had to occur during cycle 1 of treatment ]
The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).
Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
- Preliminary Efficacy [ Time Frame: For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate. ]As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705653
|United States, Illinois|
|University of Chicago, Cancer Research Centre|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Mark Ratain, M.D.||University of Chicago|