Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
This study has been completed.
Information provided by (Responsible Party):
First received: June 23, 2008
Last updated: March 21, 2012
Last verified: March 2012
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: The MTD had to occur during cycle 1 of treatment ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
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).
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
- 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 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00705653
|University of Chicago, Cancer Research Centre
|Chicago, Illinois, United States, 60637 |
||Mark Ratain, M.D.
||University of Chicago
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2008
|Results First Received:
||November 6, 2011
||March 21, 2012
||United States: Food and Drug Administration
Keywords provided by Progen Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2015