En studie av Palifosfamide Tris Plus Doxorubicin kontra Doxorubicin vid inoperabelt eller metastaserande mjukdelssarkom (PICASSO)
En fas II multicenter, parallell grupp, randomiserad studie av Palifosfamide Tris Plus doxorubicin kontra doxorubicin hos patienter med inoperabelt eller metastaserande mjukdelssarkom
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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California
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Santa Monica, California, Förenta staterna
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna
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Florida
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Tampa, Florida, Förenta staterna
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Idaho
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Coeur d'Alene, Idaho, Förenta staterna, 83814
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Illinois
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Chicago, Illinois, Förenta staterna
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Park Ridge, Illinois, Förenta staterna
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Iowa
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Iowa City, Iowa, Förenta staterna
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Kansas
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Lenexa, Kansas, Förenta staterna
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New Mexico
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Albuquerque, New Mexico, Förenta staterna
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New York
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New York, New York, Förenta staterna
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North Carolina
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Durham, North Carolina, Förenta staterna
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Oregon
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Portland, Oregon, Förenta staterna
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna
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Tennessee
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Memphis, Tennessee, Förenta staterna
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Nashville, Tennessee, Förenta staterna
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Texas
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San Antonio, Texas, Förenta staterna
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Utah
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Salt Lake City, Utah, Förenta staterna
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Washington
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Seattle, Washington, Förenta staterna
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Milan, Italien
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Padova, Italien
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Torino, Italien
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Cluj-Napoca, Rumänien, 400015
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Lasi, Rumänien
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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Age ≥18 years
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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.
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Have measurable disease as per RECIST criteria (Appendix 2)
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ECOG Performance Status of 0 or 1 (Appendix 3)
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Anthracyclin naïve
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Life expectancy of ≥12 weeks
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Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin ≤1.5×ULN (upper limit of normal)
- ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
- 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.
- Serum creatinine ≤ULN
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Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
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Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial
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Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment
Exclusion Criteria:
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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.
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Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
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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)
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History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
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Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
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History of HIV infection
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Prior nephrectomy or history of urinary tract obstruction
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Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
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Any major surgery within 3 weeks prior to start of treatment
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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).
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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)
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Pregnancy or lactation
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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
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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:
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Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
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Prior treatment with doxorubicin
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Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)
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Bone marrow transplant or stem cell rescue within 4 months of study entry
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Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
Andra namn:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
Andra namn:
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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. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
Andra namn:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Den primära effektanalysen kommer att utföras på ITT-populationen (intent-to-treat). Alla försök kommer att göras för att göra en bedömning av sjukdomsstatus var 6:e vecka tills sjukdomen fortskrider eller initiering av anticancerterapier enligt protokoll.
Tidsram: Var 6:e vecka fram till progression
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Var 6:e vecka fram till progression
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Jonathan J Lewis, MD, PhD, ZIOPHARM Oncology, Inc
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer, bindväv och mjukvävnad
- Sarkom
- Organiska kemikalier
- Kolväten
- Kolväten, cykliska
- Kolhydrater
- Polycykliska aromatiska kolväten
- Kolväten, aromatisk
- Polycykliska föreningar
- Glykosider
- Anthracykliner
- Naftakener
- Aminoglykosider
- Daunorubicin
- Doxorubicin
- isofosfamidsennep
- palifosfamide lysine
Andra studie-ID-nummer
- IPM2002
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