NL-OMON53907尚未招募2 期
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma - PTC596-ONC-008-LMS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is willing and able to provide informed consent 2. Willingness and
- •ability to comply with scheduled visits, drug administration plan, laboratory
- •tests, other study procedures, and study restrictions 3. Disease status
- •including: a. Histological or cytological confirmation of LMS arising at any
- •anatomic site except bone sarcoma b. Unresectable or metastatic, relapsed or
- •refractory disease c. Measurable disease per RECIST 1.1 criteria d. Disease
- •progression on previous treatment before screening or intolerability to other
- •oncology treatments Demographics: 4. Age >=18 years 5. Male or female
- •Performance status: 6. ECOG PS score of 0 or 1 Hematopoietic: 7. Absolute
- •neutrophil count >=1500/mm3 without the use of growth factors in the past 7 days
- •8. Platelet count >=100000/mm3 without platelet transfusion in the past 14 days
- •9. Hemoglobin >=9 g/dL (packed red blood cell transfusion is not allowed within
- •7 days) Hepatic: 10. Bilirubin <= upper limit of normal (ULN) except for those
- •patients with Gilbert's syndrome 11. Aspartate aminotransferase or alanine
- •aminotransferase <3 times the ULN 12. Subjects with liver metastases may be
- •enrolled Pulmonary: 13. Subjects with well-controlled asthma (eg, use of rescue
- •medications <2 times per week over the last 12 months) or chronic
- •obstructive pulmonary disease (eg, no exacerbations over the prior 3 months)
- •may be enrolled. Renal: 14. Creatinine <1.5 times normal OR creatinine
- •clearance >= 60 mL/min Prior therapeutics: 15. Toxicity from prior therapies
- •recovered to Grade <=1 or subject*s baseline, except for alopecia. In addition,
- •endocrinopathies associated with prior immunotherapy-based treatments that are
- •well controlled on replacement medication are not exclusionary. Chemotherapy
- •and targeted therapy: 16. 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, trabectin,
- •pazopanib, or gemcitabine with or without docetaxel Surgery: 17. At least 4
- •weeks since prior surgery and recovered in the opinion of investigator Other:
- •18. Capable of swallowing oral medication 19. Women of childbearing potential
- •(WOCBP; as defined by the Clinical Trials Facilitation and Coordination Group
- •[CTFG]) must have a negative serum pregnancy test at screening and agree to
- •abstinence or the use at least one of the following highly effective forms of
- •contraception (with a failure rate of <1% per year when used consistently
- •and correctly) (Clinical Trials Facilitation and Coordination Group 2020).
- •Contraception or abstinence must be continued for the duration of the study and
- •for at least 6 months after the last dose of study drug: • Combined (estrogen
- •and progestogen containing) hormonal contraception associated with inhibition
- •of ovulation: - Oral - Intravaginal - Transdermal • Progestogen-only hormonal
- •contraception associated with inhibition of ovulation: - Oral - Injectable -
- •Implantable • Intrauterine device • Intrauterine hormone-releasing system •
- •Bilateral tubal occlusion • Vasectomized partner with confirmed azoospermia All
- •females will be considered of childbearing potential unless they are
- •postmenopausal (at least 12 months consecutive amenorrhea in the appropriate
- •age group without oth
排除标准
- •1. Received temozolomide or DTIC at any time 2. Any other systemic anticancer
- •therapy including investigational agents <=3 weeks before initiation of study
- •treatment. Additionally, subjects may not have received radiation <=3 weeks
- •before initiation of study treatment. 3. Known intolerance to DTIC or one or
- •more of the excipients in unesbulin. 4. Co-existing active infection or any
- •co-existing medical condition likely to interfere with study procedures,
- •including: a. Significant cardiovascular disease (New York Heart Association
- •Class III or IV cardiac disease), myocardial infarction within the past 6
- •months, unstable angina, congestive heart failure requiring therapy, unstable
- •arrhythmia or a need for antiarrhythmic therapy, or evidence of ischemia on
- •ECG, marked baseline prolongation of QT/QTc (corrected QT) interval, eg,
- •repeated demonstration of a QTc interval >500 msec (Long QT Syndrome
- •[congenital]) 5. Human immunodeficiency virus, hepatitis B virus, or hepatitis
- •C virus positivity 6. History of solid organ transplantation Therapeutics: 7.
- •Known or suspected allergy or immediate or delayed hypersensitivity to
- •unesbulin or DTIC, their excipients, or any agent given in this study
- •Gastrointestinal: 8. Bowel obstruction, malabsorption, or other
- •contraindication to oral medication 9. 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
- •10. Inflammatory bowel disease (including ulcerative colitis and Crohn*s
- •disease), diverticulitis, cholecystitis, symptomatic cholangitis, or
- •appendicitis Wounds/surgery: 11. Serious non-healing wound, ulcer, or bone
- •fractures 12. Major surgery, open biopsy, or significant traumatic injury that
- •has not recovered, in the opinion of the investigator, within 28 days of
- •baseline 13. Mucosal or internal bleeding Concomitant medications: 14.
- •Concomitant strong CYP1A2 inhibitors (such as fluoroquinolones [broad spectrum
- •quinolone antibiotics, including enoxacin and ciprofloxacin] and selective
- •serotonin reuptake inhibitor [SSRI] agents fluvoxamine and fluoxetine) should
- •be avoided on the same day that DTIC or unesbulin/placebo is administered.
- •CYP1A2 inhibitors may inhibit the conversion of DTIC to its active metabolite
- •and may increase the exposure of unesbulin. 15. Concomitant use of moderate
- •CYP1A2 inducers (such as phenytoin, rifampin, ritonavir, teriflunomide, and
- •barbiturates). Chronic use of marijuna should be avoided, but irregular use may
- •be permitted at the discretion of the treating investigator. CYP1A2 inducers
- •may increase the conversion of DTIC to its active metabolites. 16.
- •Coadministration of acid-reducing agents should be avoided approximately 4
- •hours before and after unesbulin/placebo administration. 17. Immunization with
- •a live vaccine within 30 days before starting study drug due to the risk of
- •serious and life-threatening infections Other: 18. Prior malignancies, other
- •than LMS, that required treatment or have shown evidence of recurrence (except
- •for non-melanoma skin cancer, 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. Cancer treated with
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