Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
This trial is active, not recruiting.
|Condition||metastatic, locally advanced or unresectable soft tissue sarcoma|
|Treatments||aldoxorubicin, investigator's choice treatment (darcabazine, pazopanib, gemcitabine + docetaxel, doxorubicin, ifosfamide)|
|Targets||VEGF, PDGF, KIT|
|Start date||January 2014|
|End date||December 2016|
|Trial size||433 participants|
|Trial identifier||NCT02049905, ALDOXORUBICIN-P3-STS-01|
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham Cancer Center||no longer recruiting|
|Birmingham, AL||University of Alabama at Birmingham||no longer recruiting|
|Phoenix, AZ||Arizona Oncology Associates, PC||no longer recruiting|
|Tucson, AZ||The University of Arizona||no longer recruiting|
|Tucson, AZ||The University of Arizona Medical Center-University Campus||no longer recruiting|
|Denver, CA||Rocky Mountain Cancer Centers||no longer recruiting|
|Duarte, CA||City of Hope Comprehensive Cancer Center||no longer recruiting|
|Lancaster, CA||City of Hope Antelope Valley||no longer recruiting|
|Los Angeles, CA||Samuel Oschin Cancer Center||no longer recruiting|
|Los Angeles, CA||UCLA / Jonsson Comprehensive Cancer Center||no longer recruiting|
|Palo Alto, CA||Stanford Cancer Institute||no longer recruiting|
|Santa Monica, CA||Sarcoma Oncology Center||no longer recruiting|
|South Pasadena, CA||City of Hope South Pasadena||no longer recruiting|
|Stanford, CA||Stanford University Medical Center||no longer recruiting|
|Aurora, CO||University of Colorado Cancer Center - Anschutz Cancer Pavilion||no longer recruiting|
|Jacksonville, FL||Mayo Clinic in Florida||no longer recruiting|
|Tampa, FL||Moffitt Cancer Center||no longer recruiting|
|Atlanta, GA||Georgia Cancer Specialists||no longer recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Naperville, IL||Edward Cancer Center||no longer recruiting|
|Niles, IL||Oncology Specialists, SC||no longer recruiting|
|Kansas City, KS||University of Kansas Cancer Center||no longer recruiting|
|Overland Park, KS||Kansas City Cancer Center||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Dana-Farber Cancer Institute||no longer recruiting|
|Charlestown, MA||Massachusetts General Hospital||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota / Masonic Cancer Center||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|Saint Louis, MO||Siteman Cancer Center at Washington University||no longer recruiting|
|St. Louis, MO||Washington University||no longer recruiting|
|Omaha, NE||Nebraska Methodist Hospital||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|Charlotte, NC||Levine Cancer Institute||no longer recruiting|
|Winston Salem, NC||Wake Forest University Baptist Medical Center||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Health Sciences||no longer recruiting|
|Cleveland, OH||Case Comprehensive Cancer Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Columbus, OH||The James Cancer Hospital and Solove Research Institute||no longer recruiting|
|Columbus, OH||Ohio State University Comprehensive Cancer Center||no longer recruiting|
|Portland, OR||Center for Health and Healing||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson University Hospital||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Cancer Institute (UPCI)||no longer recruiting|
|Nashville, TN||Vanderbilt University||no longer recruiting|
|Nashville, TN||Vanderbilt University / Ingram Cancer Center||no longer recruiting|
|Burlington, VT||Fletcher Allen Health Care||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Saint Leonards, Australia||Royal North Shore Hospital||no longer recruiting|
|Westmead, Australia||Westmead Hospital||no longer recruiting|
|Edmonton, Canada||Cross Cancer Institute||no longer recruiting|
|Hamilton, Canada||Juravinski Cancer Center||no longer recruiting|
|Montreal, Canada||McGill University||no longer recruiting|
|Lago Puyehue, Chile||Instituto Clinico Oncologica del Sur (ICOS)||no longer recruiting|
|Herlev, Denmark||Herlev Hospital||no longer recruiting|
|Centre, France||Centre Hospitalier Regional et Universitaire - Hospital Bretonneau||no longer recruiting|
|Bordeaux Cedex, France||Institut Bergonie||no longer recruiting|
|Dijon, France||Centre Georges Francois Leclerc||no longer recruiting|
|Saint-Cloud, France||Hopital Rene Huguenin - Institut Curie||no longer recruiting|
|Villejuif, France||Institut Gustave Roussy||no longer recruiting|
|Lyon, France||Centre Leon Berard||no longer recruiting|
|Budapest, Hungary||Magyar Honvedseg Egeszsegugyi Kozpont||no longer recruiting|
|Haifa, Israel||Rambam Medical Center||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center||no longer recruiting|
|Tel-Heshomer, Israel||Chaim Sheba Medical Center||no longer recruiting|
|Ein Karem, Israel||Sharet Institute of Oncology Hadassah Ein Karem Medical Center||no longer recruiting|
|Bologna, Italy||IRCCS Instituto Ortopedico Rizzoli||no longer recruiting|
|Milano, Italy||Istituto Europeo di Oncologia Milano||no longer recruiting|
|Padova, Italy||Istituto Oncologico Veneto||no longer recruiting|
|Candiolo, Italy||Fondazione del Piemonte per l'Oncologia||no longer recruiting|
|Leiden, Netherlands||Leiden Universitair Medisch Centrum||no longer recruiting|
|Warszawa, Poland||Instytut im.Marii Sklodowskiej-Curie||no longer recruiting|
|Moscow, Russian Federation||State Institution "Blokhin Cancer Research Centre RAMS"||no longer recruiting|
|Moscow, Russian Federation||City Oncology Hospital #2||no longer recruiting|
|Tatarstan, Russian Federation||Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan||no longer recruiting|
|Barcelona, Spain||Inst Catala D'Oncologia||no longer recruiting|
|Barcelona, Spain||Hospital Santa Creu i Sant Pau||no longer recruiting|
|Castellon, Spain||Consorcio Hospitalario Provincial de Castellon||no longer recruiting|
|Madrid, Spain||Hospital San Carlos Madrid||no longer recruiting|
|Madrid, Spain||Hospital Universitario La Paz||no longer recruiting|
|Zaragoza, Spain||Hospital Universitario Miguel Servet||no longer recruiting|
|Palma de Mallorca, Spain||Hospital Universitario Son Espases||no longer recruiting|
|Majadahonda, Spain||Hospital Puerta de Hierro Majadahonda||no longer recruiting|
|Pamplona, Spain||Complejo Hospitalario de Navarra||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Progression-Free Survival (PFS)
time frame: 24 months
Overall Survival (OS)
time frame: 36 months
time frame: 24 months
Male or female participants at least 15 years old.
- Has provided written informed consent prior to any study related activities.
- Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female.
- Histological confirmation of intermediate or high grade soft-tissue sarcoma. Tissue must be sent to a central pathology lab for review but will not preclude entry onto the study. Final assignment of tumor grade and histology will be based on the designation provided by the central pathology review.
- An adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or core needle biopsy must be sent to the central pathology lab for evaluation. The material must measure at least 0.8 × 0.1 cm in size or contain at least 50 tumor cells.
- Locally advanced, unresectable, and/or metastatic soft-tissue sarcoma of intermediate or high grade with evidence of disease progression by either computed tomography (CT) or magnetic resonance imaging (MRI) scan, or clinical judgment on or after the last cancer therapy within 6 months prior to randomization.
- Relapsed or refractory (lack of response) to ≥1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation.
- Capable of providing informed consent and complying with trial procedures.
- ECOG PS 0-2.
- Life expectancy >12 weeks.
- Measurable tumor lesions according to RECIST 1.1 criteria.
- Women must not be able to become pregnant (e.g., post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 11 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and agree to continue use for 6 months after the final dose of study treatment.
- Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- Accessibility to the site that optimizes the subject's ability to keep all study-related appointments.
- Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
- Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
- Exposure to any investigational agent within 30 days of date of randomization.
- Exposure to any systemic chemotherapy within 30 days of date of randomization.
- An inadequate tumor specimen as defined by the central pathologist.
- Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear cell sarcomas.
- Evidence of central nervous system (CNS) metastasis who have not received prior definitive therapy for their lesions.
- History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥5 years.
- Laboratory values: Screening serum creatinine >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9g/dL.
- Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
- Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications.
- Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
- History or signs of active coronary artery disease with or without angina pectoris within the last 6 months.
- Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
- Known history of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. The Medical Monitor should be contacted for any uncertainties.
- Major surgery within 30 days prior to date of randomization.
- Current or past substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the subject's participation in the study.
|Official title||A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy|
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