Comparing INT230-6 with Eribulin for soft tissue sarcoma

Exclusion

• −History of severe hypersensitivity reactions to US SOCStandard of careThe treatment normally given for a condition outside a study.Read more → agents and vinblastine or cisplatin or other products of the same class and their excipients.
• −Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the participant is on a stable dose. Non-absorbed intra-articular steroid injections will be permitted. Use of steroids as prophylactic treatment for participants with contrast allergies to diagnostic imaging contrast dyes will be permitted.
• −Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy).
• −Informed ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →:
• −Adult participants who lack capacity to consent without a legally authorized representative will be excluded from this study.
• −Medical Conditions:
• −Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.
• −Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans.
• −Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years.
• −Underlying medical condition that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, will make the administration of study intervention hazardous or obscure the interpretation of toxicity determination or Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs).
• −Concurrent medical condition requiring the use of immunosuppressive medications, or systemic corticosteroids (topical steroids are permitted); systemic corticosteroids must be discontinued at least 4 weeks prior to dosing.
• −Participants who require uninterrupted anticoagulants of any type or is on daily aspirin therapy or NSAIDS.
• −Myocardial infarction within 6 months before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
• −Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures.
• −Participants with a Corrected QT interval (QTc) of \>450 ms for men and \>470 ms for women, or with a history of serum electrolyte abnormalities known to prolong the QT interval such hypocalcemia, hypokalemia, and hypomagnesemia, or a family or personal history of congenital long QT syndrome.
• −Participants actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
• −Participants actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study intervention.
• −Prior/Concomitant Therapy
• −Use of other investigational drugs (drugs not marketed for any indication) within 28 days prior to study intervention administration.
• −Received a live vaccine within 6 weeks of first dose of study intervention.
• −Received a Coronavirus Disease (COVID-19) vaccine less than 1 week prior to dosing (Cycle 1/Day 1) and/or during the study received a COVID-19 vaccine or booster less than 3 weeks ahead of a tumor assessment.
• −Other Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• −Pregnancy Exclusion: A WOCBP who has a positive pregnancy test (e.g., within 72 hours) prior to treatment. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• −Prior chemotherapy or immunotherapy (tumor vaccine, cytokine or growth factor given to controlControl groupThe group a new treatment is measured against.Read more → the cancer: systemic or IT) must have been completed at least 4 weeks prior to dosing (with the exception of kinase inhibitors or other short half-life drugs, a 2-week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → is acceptable prior to treatment) and all AEs have either returned to baselineBaselineYour starting measurements, taken before treatment begins.Read more → or stabilized. Note: participants who have received prior platinum therapy are eligible irrespective of their response. If participant had received one of the 3 US SOC study regimens prior to enrollment, that previous US SOC cannot be assigned in this study.
• −Prior systemic radiation therapy (IV, intrahepatic or oral) completed at least 4 weeks prior to study intervention administration. Prior focal radiotherapy completed at least 2 weeks prior to study intervention administration.
• −a. Prior major treatment-related surgery completed at least 4 weeks prior to study intervention administration.