Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06239272 · ClinicalTrials.gov registry record · Phase 1
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
A Phase 1 study of Liposarcoma and Angiosarcoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
- 6
- Study locations
NCT06239272 is a Phase 1 study of Liposarcoma and Angiosarcoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 139 participants, above the 74-participant average among 13 other Liposarcoma trials with a reported enrollment target (88% higher). The trial reports 6 study locations across 6 states.
The verdict
NCT06239272, a Phase 1 study of Liposarcoma and Angiosarcoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk * To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT. * To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics. High-Risk * To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants. * To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics. Secondary Objectives * To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol. * To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants. * To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity. * To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, do
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Ifosfamide
- PROCEDURE Surgical resection
- DRUG Pazopanib
- RADIATION Proton beam radiation therapy
Study Locations (6)
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Louisiana
- Our Lady of the Lake Children's Hospital - Baton Rouge
Massachusetts
- Dana Farber Cancer Institute - Boston
Missouri
- Washington University Medical Center - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2024-03-27 |
| Est. Completion | 2037-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06239272
The ClinicalTrials.gov registry entry for NCT06239272 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 74-participant average among 13 other Liposarcoma trials with a reported enrollment target (88% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Liposarcoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT06239272 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Illinois, Louisiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06239272 about?
NCT06239272 is a clinical study titled "NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)". The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk * To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT. * T...
What is the current status of trial NCT06239272?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2024-03-27. Estimated completion is 2037-06.
What conditions does trial NCT06239272 study?
This clinical trial studies the following conditions: Liposarcoma, Angiosarcoma, Myxofibrosarcoma, Atypical Fibroxanthoma, Angiomatoid Fibrous Histiocytoma.
What interventions are being tested in trial NCT06239272?
The interventions under investigation include: Doxorubicin (DRUG), Ifosfamide (DRUG), Surgical resection (PROCEDURE), Pazopanib (DRUG), Proton beam radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT06239272?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06239272 being conducted?
This trial has 6 study locations across Illinois, Louisiana, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liposarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
RECRUITING · Phase 1
-
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
RECRUITING · Phase 1
-
BTX-A51 in Patients With Liposarcoma or CIC-rearranged Sarcoma
RECRUITING · Phase 1
-
Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
RECRUITING · Phase 1
-
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
RECRUITING · Phase 1
-
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.