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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
Sponsor:
Information provided by (Responsible Party):
Progen Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: PG-11047 Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
Study Start Date : March 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: PG-11047 Drug: PG-11047
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).



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, Illinois
University of Chicago, Cancer Research Centre
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Principal Investigator: Mark Ratain, M.D. University of Chicago

Additional Information:
Responsible Party: Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00705653     History of Changes
Other Study ID Numbers: 47-01-001
First Posted: June 26, 2008    Key Record Dates
Results First Posted: February 27, 2012
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by Progen Pharmaceuticals:
cancer
advanced cancer
solid tumors
CGC-11047
PG-11047

Additional relevant MeSH terms:
N(1),N(11)-diethylnorspermine
Antihypertensive Agents
Antineoplastic Agents