Phase 3 Study to Treat Patients With Soft Tissue Sarcomas Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on June 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified June 2017 by ImmunityBio, Inc.

Sponsor

ImmunityBio, Inc.

Information Provided by (Responsible Party)

ImmunityBio, Inc.

Clinicaltrials.gov Identifier

NCT02049905
Other Study ID Numbers: ALDOXORUBICIN-P3-STS-01
First Submitted: January 28, 2014
First Posted: January 30, 2014
Results First Posted: June 13, 2024
Last Update Posted: June 13, 2024
Last Verified: June 2017
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma	Drug: Aldoxorubicin Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)

Study Design

Study Type	Interventional
Actual Enrollment	433 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
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
Study Start Date	January 2014
Actual Primary Completion Date	May 2017
Actual Study Completion Date	May 2017

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
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
Investigator's Choice of Treatment These treatments include: 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; Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs; 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; 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 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)

Outcome Measures

Primary Outcome Measures

Progression-Free Survival (PFS) [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.

Eligibility Criteria

Ages Eligible for Study	15 Years and Older (Child, Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	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.[50] 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.
Exclusion Criteria	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.

Contacts and Locations

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

Study Documents (Full Text)

Documents Provided by ImmunityBio, Inc.: Study Protocol and Statistical Analysis Plan January 21, 2016

More Information

Additional Information

Additional Relevant MeSH Terms

Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms