Clinical trial · Interventional
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
A Phase I/II Study of Nelfinavir in Liposarcoma
NCT00233948CI-TRIAL-00017348terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug availability issues
Summary
Brief summary (as posted)
RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading. PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Liposarcoma | Adult Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IV Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nelfinavir mesylate | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: nelfinavir mesylate
- Procedure: biopsy
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Genetic: gene expression analysis
- Genetic: western blotting
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: immunoenzyme technique
Primary outcomes (3)
- measure
- Dose Limiting Toxicity (DLT) (Phase I)
- timeFrame
- 4 weeks from start of treatment, up to 2 years
- description
- DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Patients must have histologically confirmed liposarcoma, which is recurrent, metastatic or unresectable * There is no limit to prior chemotherapy regimens; in addition, patients may have prior radiation * All patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (\>= 20 mm with conventional techniques or \>= 10mm with spiral CT scan); pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s) * ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2; patients should have an expected survival of at least 3 months * Absolute neutrophil count \>= 1,000/ul * Platelets \>= 75000/ul * Total bilirubin =\< 2.0 g/dl * AST(SGOT)/ALT(SGPT) =\< 2.0X institutional upper limit of normal * Brain metastasis is not an exclusion; however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or radiation therapy * All prior therapy must have been completed at least 3 weeks prior to the patient's entry on this trial * No concurrent chemotherapy, radiotherapy, immunotherapy or other investigational agents * Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and willingness to sign a written informed consent document Exclusion * Patient has had prior treatment with or is currently taking a protease inhibitor * Patients enrolled cannot be on the following medications: cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, dihydropyridine calcium antagonists (amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine), sildenafil, dilantin, rifampin or oral contraceptives * Uncontrolled intercurrent illness * Patients must have recovered from any expected toxicities of previous chemotherapy or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.