Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PG-11047

Drug
Who is being recruted

Neoplasms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2005
See protocol details

Summary

Principal SponsorProgen Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
NCT00705653
Principal SponsorProgen Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

3 inclusion criteria required to participate
non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
ECOG - 0-2.
Life expectancy > 3 months.
4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Chicago, Cancer Research Centre

Chicago, United StatesOpen University of Chicago, Cancer Research Centre in Google Maps
CompletedOne Study Center