Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie av Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin i uoperabelt eller metastatisk bløtvevssarkom (PICASSO)

1. oktober 2026 oppdatert av: Alaunos Therapeutics

En fase II multisenter, parallell gruppe, randomisert studie av Palifosfamide Tris Plus Doxorubicin versus Doxorubicin hos personer med uoperabelt eller metastatisk bløtvevssarkom

This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Santa Monica, California, Forente stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater
    • Florida
      • Tampa, Florida, Forente stater
    • Idaho
      • Coeur d'Alene, Idaho, Forente stater, 83814
    • Illinois
      • Chicago, Illinois, Forente stater
      • Park Ridge, Illinois, Forente stater
    • Iowa
      • Iowa City, Iowa, Forente stater
    • Kansas
      • Lenexa, Kansas, Forente stater
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
    • New York
      • New York, New York, Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater
    • Oregon
      • Portland, Oregon, Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
    • Tennessee
      • Memphis, Tennessee, Forente stater
      • Nashville, Tennessee, Forente stater
    • Texas
      • San Antonio, Texas, Forente stater
    • Utah
      • Salt Lake City, Utah, Forente stater
    • Washington
      • Seattle, Washington, Forente stater
  • Italia
      • Milan, Italia
      • Padova, Italia
      • Torino, Italia
  • Romania
      • Cluj-Napoca, Romania, 400015
      • Lasi, Romania

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years

  2. Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.

  3. Have measurable disease as per RECIST criteria (Appendix 2)

  4. ECOG Performance Status of 0 or 1 (Appendix 3)

  5. Anthracyclin naïve

  6. Life expectancy of ≥12 weeks

  7. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:

    1. Hemoglobin ≥9.0 g/dL
    2. Absolute neutrophil count (ANC) ≥1,500/mm3
    3. Platelet count 100,000/mm3
    4. Total bilirubin ≤1.5×ULN (upper limit of normal)
    5. ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
    6. Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen). Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate.
    7. Serum creatinine ≤ULN

  8. Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures

  9. Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial

  10. Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment

Exclusion Criteria:

  1. Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.

  2. Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)

  3. Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)

  4. History and/or signs of active coronary artery disease/ischemia with or without angina pectoris

  5. Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%

  6. History of HIV infection

  7. Prior nephrectomy or history of urinary tract obstruction

  8. Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy

  9. Any major surgery within 3 weeks prior to start of treatment

  10. Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).

  11. Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies curatively treated >5 years prior to entry)

  12. Pregnancy or lactation

  13. Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results

  14. Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements

    In addition, use of the following therapies and medications-prior or concomitant-would exclude a subject from this study:

  15. Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)

  16. Prior treatment with doxorubicin

  17. Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)

  18. Bone marrow transplant or stem cell rescue within 4 months of study entry

  19. Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Palifosfamide-Tris Plus Doxorubicin

Participants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment.
Legemiddel: Palifosfamide-Tris

Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.

Andre navn:
  • ZIO-201
  • isophosphoramide mustard
Legemiddel: Doxorubicin

Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.

Andre navn:
  • Adriamycin
Aktiv komparator: Doxorubicin Alone With Optional Palifosfamide-Tris After Progression

Participants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment.
Legemiddel: Palifosfamide-Tris

Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.

Andre navn:
  • ZIO-201
  • isophosphoramide mustard
Legemiddel: Doxorubicin

Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.

Andre navn:
  • Adriamycin

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Den primære effektanalysen vil bli utført på intent-to-treat-populasjonen (ITT). Alle forsøk vil bli gjort på å foreta vurdering av sykdomsstatus hver 6. uke inntil sykdomsprogresjon eller initiering av antikreftbehandlinger uten protokoll.
Tidsramme: Hver 6. uke frem til progresjon
Hver 6. uke frem til progresjon

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alaunos Therapeutics

Etterforskere

  • Studieleder: Jonathan J Lewis, MD, PhD, ZIOPHARM Oncology, Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. september 2008

Primær fullføring (Faktiske)

20. september 2010

Studiet fullført (Faktiske)

20. september 2010

Datoer for studieregistrering

Først innsendt

16. juli 2008

Først innsendt som oppfylte QC-kriteriene

17. juli 2008

Først lagt ut (Antatt)

18. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IPM2002

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere