[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"open-label\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:open-label":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643791","phase-1-a-phase-1b-open-label-study-of-rec-617-a-selective-cdk7-inhibitor-in-patients-with-metastatic-or-unresectable-rb1-negative-leiomyosarcoma-after-prior-systemic-therapy-100643791",false,"NCT07633756","A Phase 1b, Open-Label Study Of REC-617, A Selective CDK7 Inhibitor, In Patients With Metastatic Or Unresectable RB1-Negative Leiomyosarcoma After Prior Systemic Therapy","Eligibility Criteria A. Disease Characteristics\n\n* Histologically confirmed leiomyosarcoma (any site of origin).\n* RB1-negative tumor, as assessed by immunohistochemistry (IHC) with a cutoff of 0% versus any expression Participants will have measurable diseases by RECIST 1.1. Previously ablated\u002F radiated\u002Ftreated areas can only be counted towards measurable disease if there is unequivocal progression after directed therapy.\n* Participant will have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases, as confirmed by a radiologist, if appropriate, and as deemed safe by the Investigator. If there is only one target lesion per RECIST 1.1 which is accessible to biopsy, this lesion should be at least 2cm.\n\nB. Prior and Current Therapy Requirements\n\n* At least one prior line of systemic therapy. C. Participants Characteristics\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of REC-617 in Participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤ 2 (Karnofsky ≥60%,).\n* Life expectancy of \\>3 months, as determined by the investigator.\n* Ability to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document and comply with study procedures.\n\nD. Organ and Marrow Function Requirements\n\nParticipants will have adequate organ and marrow functions as defined below:\n\nHemoglobin ≥8.5 g\u002FdL. Absolute neutrophil count ≥1,000\u002FmcL Platelets ≥150,000\u002FmcL, no platelet transfusion within 7 days prior to screening visit Total bilirubin ≤ institutional upper limit of normal (ULN) (except Participants with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN INR ≤1.5 except for Participants on oral anticoagulants Creatinine clearance ≥60 mL\u002Fmin based on the Cockcroft-Gault equation or method standard to institution E. Viral and Infectious Disease Requirements\n\n* Participants may not have active or chronic infections with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) F. CNS and Cardiac Requirements\n* Participants with asymptomatic treated CNS lesions who have completed treatment ≥30 days prior with documented stability on imaging and are on a stable steroid dose are eligible.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, Participants should be class 2B or better.\n* Participants should not have a QTcF \\>470 msec or history of torsades de pointes or history of congenital long QT syndrome.\n\nG. Reproductive\u002FContraception Requirements\n\nThe effects of REC-617 on the developing human fetus are unknown. For this reason and because CDK7 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men will agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  * Participants are eligible to participate if they agree to use 2 methods of contraception, approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nMen and women treated or enrolled on this protocol will also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of REC-617 administration.\n\nExclusion Criteria A. Concurrent Treatments and Investigational Agents\n\n* Participants who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.\n* Current enrollment in another clinical study unless it is non-interventional or the follow-up period of an interventional study.\n* Prior treatment with radiotherapy (including radio-labeled spheres and\u002For cyberknife, hepatic arterial embolization (with or without chemotherapy) or cryotherapy\u002Fablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.\n* Received medications known to prolong QTc within 5 half-lives before the first dose of the study treatment. List of medications that prolong QTc can be obtained from crediblemeds.org.\n* Administration of a live vaccine within 28 days of starting study treatment and for up to 1 month after the final dose of study treatment or anticipation that such vaccine will be required during the study. Note: mRNA-based vaccines for COVID-19 are allowed as well as inactivated flu vaccines.\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nB. Disease or Cancer-Related Exclusions\n\n* Active concurrent second malignancy within 2 years of trial enrollment. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.\n* Unresolved or unstable toxic side-effects of prior anticancer therapy, except fatigue, alopecia, infertility, peripheral neuropathy, or those relating to palliative radiotherapy within 6 weeks prior to first dose of study treatment will have resolved to Grade 1 or less.\n\nC. Other comorbidities affecting participation\n\n* Active gastrointestinal bleeding.\n* Evidence of severe or uncontrolled systemic disease or psychiatric illness that, in the investigator's judgment, would limit safety or compliance.\n* Impaired gastrointestinal absorption\n* History of allergic reactions to compounds like REC-617. D. Transplant History\n* Prior organ or allogeneic stem-cell transplantation","ALL","18 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn if the study drug REC-617 can help to control LMS. The safety of REC-617 will also be studied.",[25,26,27,28,29],"Phase 1b","Open Label","REC-617","RB1-Negative","Leiomyosarcoma","RECRUITING","2026-07-29",{"date":33,"type":34},"2026-07-31","ACTUAL",{"date":36,"type":19},"2026-10-19",{"date":38,"type":19},"2031-12-26",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443","NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","50 Years",{"count":52,"type":19},30,[22],"A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[56,57,58,59,60,61],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":65,"type":34},"2026-06-23",{"date":67,"type":19},"2026-06-15",{"date":69,"type":19},"2027-05-05",{"name":71,"class":72},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7]