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NCT Number: NCT00705653

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago, Cancer Research Centre

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG-11047

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Progen Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 26, 2008
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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