Clinical trial · Interventional
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
NCT00705653CI-TRIAL-00006605completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PG-11047 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PG-11047
- interventionNames
- Drug: PG-11047
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- The MTD had to occur during cycle 1 of treatment
- description
- 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)
- measure
- Preliminary Efficacy
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMurray 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