Leiomyosarcoma Clinical Trial
— SUNRISELMSOfficial title:
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
Verified date | June 2024 |
Source | PTC Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma, unresectable or metastatic, relapsed or refractory disease measurable per RECIST 1.1 criteria - Disease progression on previous treatment before screening or intolerability to other oncology treatments - Participants with liver metastases may be enrolled - Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled. - Toxicity from prior therapies recovered to Grade =1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy-based treatments that are well controlled on replacement medication are not exclusionary. - At least 1 prior systemic cytotoxic or targeted therapy regimen for LMS, which may include but is not limited to single-agent doxorubicin or other anthracycline, doxorubicin plus ifosfamide, trabectedin, pazopanib, or gemcitabine with or without docetaxel. - At least 4 weeks since prior surgery and recovered in the opinion of investigator Key Exclusion Criteria: - Received temozolomide or dacarbazine at any time - Any other systemic anticancer therapy including investigational agents =3 weeks before initiation of study treatment. Additionally, participants may not have received radiation =3 weeks before initiation of study treatment. - Known intolerance to dacarbazine or one or more of the excipients in unesbulin. - Co-existing active infection or any co-existing medical condition likely to interfere with study procedures - Gastrointestinal disease or other conditions that could affect absorption. Active peptic ulcer disease, active gastritis, or previous history of gastric perforation within the last 2 years - Major surgery, open biopsy, or significant traumatic injury that has not recovered, in the opinion of the investigator, within 28 days of baseline - Immunization with a live vaccine within 30 days before starting study drug due to the risk of serious and life-threatening infections. - Prior malignancies, other than LMS, that required treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ, prostate cancer in situ or any other low risk malignancy that is approved by the medical monitor) during the 5 years before initiation. - Prior or ongoing clinically significant illness, medical or psychiatric condition, medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, or alter the absorption, distribution, metabolism, or excretion of the study drugs, or could impair the assessment of study results. Note: Other inclusion and exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Chris O'Brien Lifehouse | Camperdown | |
Australia | Peter MacCallum Cancer Institute | East Melbourne | |
Australia | Prince of Wales Hospital | Randwick | |
Brazil | Fundacao PIO XII - Hospital de Amor | Barretos | |
Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | |
Brazil | INCA I - Instituto Nacional de Cancer | Rio de Janeiro | |
Brazil | Hospital Sao Rafael - Instituto D'Or da Bahia | Salvador | |
Brazil | CIP - Centro Integrado de Pesquisas do Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | |
Brazil | Instituto do Cancer do Estado de São Paulo (ICESP) | São Paulo | |
Canada | Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR) | Montreal | Quebec |
Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
France | Institut Bergonie | Bordeaux Cedex | |
France | Centre Leon Berard | Lyon | |
France | Institut Curie | Paris | |
France | Gustave Roussy | Villejuif cedex | |
Germany | Universitaetsmedizin Mannheim | Mannheim | |
Germany | Klinikum der Ludwig-Maximilians-Universitaet Muenchen | Munchen | |
Hungary | Eszak-Pesti Centrumkorhaz - Honvedkorhaz | Budapest | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | |
Italy | La Fondazione e l'Istituto di Candiolo | Torino | |
Netherlands | Leids Universitair Medisch Centrum | Leiden | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej Zespól Poradni Specjalistycznych "TERMEDICA" | Poznan | |
Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow | Warszawa | |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Institut Catala d'Oncologia (Hospital Duran y Reynals) | Barcelona | |
Spain | Hospital Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
United Kingdom | Beatson, West of Scotland Cancer Centre | Glasgow | |
United Kingdom | Royal Marsden Hospital | London | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Johns Hopkins Oncology Group | Baltimore | Maryland |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | The Ohio State University (OSU) | Columbus | Ohio |
United States | University of Colorado Denver | Denver | Colorado |
United States | City of Hope | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of California, Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | Yale University | New Haven | Connecticut |
United States | David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York |
United States | The Trustees of Columbia University | New York | New York |
United States | University of Florida (UF) Health Cancer Center - Orlando Health | Orlando | Florida |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Washington University | Saint Louis | Missouri |
United States | Sarcoma Oncology Research Center | Santa Monica | California |
United States | Stanford Cancer Center | Stanford | California |
United States | Moffitt | Tampa | Florida |
United States | Northwestern Medicine - Warrenville Cancer Center | Warrenville | Illinois |
Lead Sponsor | Collaborator |
---|---|
PTC Therapeutics |
United States, Australia, Brazil, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Assessed by an Independent Central Imaging Laboratory | From the date of randomization to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 2 years) | ||
Secondary | Overall Survival | From the date of randomization to the date of death due to any cause (up to approximately 2 years) | ||
Secondary | Objective Response Rate (ORR) | ORR is defined as the number of participants who achieve a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST 1.1 as per independent radiologist assessment. | From the date of randomization until the date of objectively documented progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years) | |
Secondary | Disease Control Rate (DCR) | DCR is defined as the number of participants with BOR of CR, PR, or at least 3 months of stable disease using RECIST 1.1 as per independent radiologist assessment. | From the date of randomization until the date of the first documented tumor progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years) | |
Secondary | Duration of Response per RECIST 1.1 Assessed by an Independent Central Imaging Laboratory | Time from the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 2 years) | ||
Secondary | Number of Participants with Treatment-emergent Adverse Events | From the date of randomization up to approximately 2 years |
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