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

NCT00705653 | Completed Phase 1 Results

• 1 other identifier: 47-01-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

cancer; advanced cancer; solid tumors; CGC-11047; PG-11047

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  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.

  The MTD had to occur during cycle 1 of treatment

Secondary Outcomes (1)

• Preliminary Efficacy

  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.

Study Arms (1)

PG-11047

EXPERIMENTAL

Drug: PG-11047

Interventions

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).

PG-11047

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
• ECOG - 0-2.
• Life expectancy \> 3 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Progen Pharmaceuticals: lead

Study Sites (1)

University of Chicago, Cancer Research Centre

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Murray Stewart T, Desai AA, Fitzgerald ML, Marton LJ, Casero RA Jr. A phase I dose-escalation study of the polyamine analog PG-11047 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2020 Jun;85(6):1089-1096. doi: 10.1007/s00280-020-04082-4. Epub 2020 May 23.

  PMID: 32447421 DERIVED

Related Links

• Progen Pharmaceuticals website

MeSH Terms

Conditions

Neoplasms

Interventions

(N(1),N(12))bis(ethyl)-6,7-dehydrospermine

Results Point of Contact

• Title: Michael Fitzgerald
• Organization: Progen Industries

michaelf@progen-pharma.com

919-803-9988

Study Officials

• Mark Ratain, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: March 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 27, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-03

Locations

US (1)