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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05269355
Other study ID # PTC596-ONC-008-LMS
Secondary ID 2022-000073-12
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 23, 2022
Est. completion date June 30, 2024

Study information

Verified date June 2024
Source PTC Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Unesbulin
Unesbulin will be administered as per the dose and schedule specified in the arm description.
Dacarbazine
Dacarbazine will be administered as per the dose and schedule specified in the arm description.
Other:
Placebo
Placebo will be administered as per the schedule specified in the arm description.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
PTC Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

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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