CancerPhase 1NCT00705653
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
A Phase 1 study testing PG-11047 in people with Cancer, run by Progen Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PG-11047
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
- ECOG - 0-2.
- Life expectancy > 3 months.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago, Cancer Research Centre
Chicago, Illinois, 60637
About this study
Official title: A Phase I Study of CGC-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.
Read the 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.
- Conditions
- Cancer
- Being tested
- PG-11047
- Keywords
- cancer, advanced cancer, solid tumors, CGC-11047, PG-11047
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-11047Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| PG-11047 | Experimental | Not described Receives: Drug: PG-11047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The MTD had to occur during cycle 1 of treatment
Secondary outcomes (1)
Preliminary Efficacy
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startMar 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Ratain, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705653
- Sponsor's protocol ID
- 47-01-001
- Status last verified
- Mar 2012
- First submitted
- 23 Jun 2008
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32447421
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00705653
- Acronym / sponsor ID
- 47-01-001
- Conditions
- Cancer
- Keywords
- cancer, advanced cancer, solid tumors, CGC-11047, PG-11047
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Progen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PG-11047 | Experimental | Drug: PG-11047 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
- ECOG - 0-2.
- Life expectancy > 3 months.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG-11047PG-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). | Drug | PG-11047 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32447421Murray 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.
- Progen Pharmaceuticals websiteLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ratain, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PG-11047 in people with Cancer, run by Progen Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: The MTD had to occur during cycle 1 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.