Phase 3 Study to Treat Patients With Soft Tissue Sarcomas

June 12, 2024 updated by: ImmunityBio, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia
        • Westmead Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, LBV5C2
        • Juravinski Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H2W156
        • McGill University
  • Chile
    • Araucanía
      • Temuco, Araucanía, Chile
        • Instituto Clinico Oncologica del Sur (ICOS)
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
  • France
    • Aquitaine
      • Bordeaux Cedex, Aquitaine, France
        • Institut Bergonie
    • Bourgogne
      • Dijon, Bourgogne, France
        • Centre Georges Francois Leclerc
    • Centre-Val-de-Loire
      • Tours, Centre-Val-de-Loire, France
        • Centre Hospitalier Regional et Universitaire - Hospital Bretonneau
    • Ile-de-France
      • Saint-Cloud, Ile-de-France, France
        • Hôpital René Huguenin - Institut Curie
      • Villejuif, Ile-de-France, France, 94800
        • Institut Gustave Roussy
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France
        • Centre Léon Bérard
  • Hungary
      • Budapest, Hungary
        • Magyar Honvedseg Egeszsegugyi Kozpont
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Sharet Institute of Oncology Hadassah Ein Karem Medical Center
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna-Policlinico S Orsola-Malpighi
      • Bologna, Italy
        • IRCCS Instituto Ortopedico Rizzoli
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia Milano
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
    • Torino
      • Candiolo, Torino, Italy
        • Fondazione del Piemonte per l'Oncologia
  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Leiden Universitair Medisch Centrum
  • Poland
      • Warszawa, Poland
        • Instytut im.Marii Sklodowskiej-Curie
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • State Institution "Blokhin Cancer Research Centre RAMS"
      • Moscow, Russian Federation, 143423
        • City Oncology Hospital #2
      • Tatarstan, Russian Federation, 420029
        • Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan
  • Spain
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Inst Catala D'Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro
      • Madrid, Spain
        • Hospital San Carlos Madrid
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 08025
        • Hospital Universitario Son Espases
    • Castellon
      • Castellón de la Plana, Castellon, Spain
        • Consorcio Hospitalario Provincial de Castellon
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Hospital Puerta de Hierro Majadahonda
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC
      • Tucson, Arizona, United States, 85719
        • The University of Arizona
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90048
        • Samuel Oschin Cancer Center
      • Santa Monica, California, United States, 940403
        • Sarcoma Oncology Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • U of CO Health Sciences Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
      • Naperville, Illinois, United States, 60540
        • Edward Cancer Center
      • Niles, Illinois, United States, 60714
        • Oncology Specialists, SC
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43202
        • The James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Center for Health and Healing
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Medical College
      • Pittsburgh, Pennsylvania, United States, 15232
        • U of Pittsburgh Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has provided written informed consent prior to any study related activities.
  2. Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Capable of providing informed consent and complying with trial procedures.
  8. ECOG PS 0-2.
  9. Life expectancy >12 weeks.
  10. Measurable tumor lesions according to RECIST 1.1 criteria.[50]
  11. 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.)
  12. 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.
  13. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
  14. Accessibility to the site that optimizes the subject's ability to keep all study-related appointments.

Exclusion Criteria:

  1. Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
  2. Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
  3. Exposure to any investigational agent within 30 days of date of randomization.
  4. Exposure to any systemic chemotherapy within 30 days of date of randomization.
  5. An inadequate tumor specimen as defined by the central pathologist.
  6. 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.
  7. Evidence of central nervous system (CNS) metastasis who have not received prior definitive therapy for their lesions.
  8. 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.
  9. 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.
  10. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
  11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  12. Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications.
  13. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
  14. History or signs of active coronary artery disease with or without angina pectoris within the last 6 months.
  15. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
  16. Known history of HIV infection.
  17. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. The Medical Monitor should be contacted for any uncertainties.
  18. Major surgery within 30 days prior to date of randomization.
  19. 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.
  20. Any condition that is unstable and could jeopardize the subject's participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aldoxorubicin
Aldoxorubicin is administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs.
Drug: Aldoxorubicin
Other Names:
  • INNO-206
Active Comparator: Investigator's Choice of Treatment

These treatments include:

  1. Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs;
  2. Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs;
  3. Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs;
  4. Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or
  5. Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs.
Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
Other Names:
  • Doxorubicin
  • Darcabazine
  • Pazopanib
  • Gemcitabine + Docetaxel
  • Ifosfamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 24 months

PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment.

PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first.

PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 36 months
Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.
36 months
Safety Measures
Time Frame: 24 months
The safety of aldoxorubicin compared to investigator's choice in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunityBio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimated)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALDOXORUBICIN-P3-STS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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