Clinical trial · Interventional
PR-104 in Treating Patients With Advanced Solid Tumors
A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors
NCT00349167CI-TRIAL-00008559completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| PR-104 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PR-104
- description
- PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2
- interventionNames
- Drug: PR-104
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria: * Not amenable to standard therapy * Refractory to conventional therapy * Measurable or evaluable disease PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin \> 9 g/L (transfusion independent) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * Creatinine clearance ≥ 60 mL/min * PT/INR or aPTT ≤ 1.1 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * No significant cardiac comorbidity including any of the following: * New York Heart Association class III-IV congenital heart failure * LVEF \< 40% * Unstable angina * Myocardial infarction within the past 6 months * Ventricular arrhythmias requiring drug therapy * Pacemaker or implanted defibrillator * No ongoing coagulopathy * No uncontrolled infection or infection requiring parenteral antibiotics * No other significant clinical disorder or laboratory finding that would preclude study treatment * No known HIV positivity * No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests * No known allergy to nonplatinum-containing alkylating agents PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy) * More than 4 weeks since prior major surgery * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 4 weeks since prior radiotherapy * More than 1 month since prior investigational drugs, therapies, or devices * No prior radiotherapy to \> 25% of bone marrow * No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant) * No more than 3 prior myelosuppressive chemotherapy regimens * Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month * Nasal, opthalmologic, and topical glucocorticoid preparations allowed * Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency) * No concurrent prophylactic hematopoietic growth factors * No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes * Radioisotopes for protocol specified positron emission tomography allowed * No other concurrent investigational agents * No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)
References
Publications (1)
- RESULTJameson MB, Rischin D, Pegram M, Gutheil J, Patterson AV, Denny WA, Wilson WR. A phase I trial of PR-104, a nitrogen mustard prodrug activated by both hypoxia and aldo-keto reductase 1C3, in patients with solid tumors. Cancer Chemother Pharmacol. 2010 Mar;65(4):791-801. doi: 10.1007/s00280-009-1188-1. Epub 2009 Dec 10. PMID 20012293