[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05691491":3,"trial-entities:NCT05691491":417,"trial-summary:NCT05691491":423},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":121,"secondary_outcomes":126,"sex":140,"minimum_age":141,"maximum_age":142,"healthy_volunteers":15,"eligibility_criteria":143,"std_ages":179,"locations":182,"central_contacts":411,"overall_officials":412,"references":415,"see_also_links":416},"NCT05691491","NCI-2022-10211","Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness","A Phase 1\u002F2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774","RECRUITING","2027-03-01","2026-06","2026-07-31","2023-09-28","National Cancer Institute (NCI)","NIH",false,"This phase I\u002FII trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.","PRIMARY OBJECTIVE:\n\nI. To determine the maximum tolerated dose of the combination of temozolomide (TMZ) and tuvusertib (M1774).\n\nSECONDARY OBJECTIVES:\n\nI. To observe and record anti-tumor activity. II. To determine the overall response rate. III. To estimate progression free survival. IV. To estimate overall survival. V. To determine the recommended phase 2 dose of the combination of TMZ and M1774.\n\nEXPLORATORY OBJECTIVES:\n\nI. Correlate MGMT promoter hypermethylation, MGMT expression and tumor-infiltrating lymphocytes (TILs) with efficacy endpoints of response rate, progression free survival, and overall survival.\n\nII. Assess pre and post treatment tumor biopsies for changes in tumor mutational burden, tumor associated neo-antigens and microsatellite status by whole exome sequencing.\n\nIII. Measure changes in peripheral blood mononuclear cell populations with treatment.\n\nIV. Assess liquid biopsies by circulating tumor (ct)DNA for changes in tumor mutational burden and microsatellite status by whole exome sequencing.\n\nOUTLINE: This is a phase I, dose-escalation study of temozolomide and tuvusertib followed by a phase II study.\n\nPatients receive tuvusertib orally (PO) once daily (QD) on days 1-7 and temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and magnetic resonance imaging (MRI) as well as collection of blood samples throughout the trial. Patients also undergo a biopsy at baseline and may undergo one on study and\u002For time of progression.\n\nAfter completion of study treatment, patients are followed up at 4 weeks (if clinically indicated), and then every 3 months for up to 2 years.",[19,20,21,22,23,24,25],"Advanced Malignant Solid Neoplasm","Advanced Microsatellite Stable Colorectal Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Metastatic Malignant Solid Neoplasm","Metastatic Microsatellite Stable Colorectal Carcinoma","Stage III Colorectal Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8",[],"INTERVENTIONAL","TREATMENT",[30,31],"PHASE1","PHASE2",{"count":33,"type":34},42,"ESTIMATED",[36,46,55,72,92,112],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[41],"Treatment (tuvusertib, temozolomide)",[43,44,45],"Biopsy","BIOPSY_TYPE","Bx",{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Biospecimen Collection","Undergo collection of blood samples",[41],[51,52,53,54],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":37,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Computed Tomography","Undergo CT scan",[41],[60,61,62,63,64,65,66,67,68,69,70,71],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":37,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Magnetic Resonance Imaging","Undergo MRI",[41],[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"DRUG","Temozolomide","Given orally (PO)",[41],[98,99,100,101,102,103,104,105,106,107,108,109,110,111],"CCRG-81045","Gliotem","Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-","M & B 39831","M and B 39831","Methazolastone","RP-46161","SCH 52365","Temcad","Temizole","Temodal","Temodar","Temomedac","TMZ",{"type":93,"name":113,"description":114,"armGroupLabels":115,"otherNames":116},"Tuvusertib","Given PO",[41],[117,118,119,120],"ATR Kinase Inhibitor M1774","M 1774","M-1774","M1774",[122],{"measure":123,"description":124,"timeFrame":125},"Dose limiting toxicity and the maximum tolerated dose","Defined as adverse events meeting the criteria that are at least \"possibly related\" to TMZ or M1774. Dose limiting toxicity for temozolomide in combination with M1774 and the maximum tolerated dose or maximum safe dose. Will consider ten dose levels (dose level -2, -1, 1, 2, 3, 4, 5, 6, 7, 8). The Bayesian Optimal Interval (BOIN) design based on the cumulative number of patients who experience a dose-limiting toxicity (DLT) at the current dose level will be used to guide dose escalation.","Up to 28 days",[127,131,135,137],{"measure":128,"description":129,"timeFrame":130},"Objective response rate (ORR)","Will report the ORR and corresponding 2-sided 90% exact confidence intervals using the Clopper-Pearson method.","Up to 2 years after completion of study treatment",{"measure":132,"description":133,"timeFrame":134},"Progression free survival (PFS)","Will be estimated using Kaplan-Meier method. Median survival times will be estimated. The confidence intervals for the median will be calculated.","From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years after completion of study treatment",{"measure":136,"description":133,"timeFrame":130},"Overall survival (OS)",{"measure":138,"description":139,"timeFrame":130},"Rate of >= grade 3 adverse events (AE)","The revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be utilized for AE reporting.","ALL","18 Years",null,{"inclusion":144,"exclusion":168,"raw_text":178},[145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167],"Patients must have histologically or cytologically confirmed diagnosis of metastatic advanced cancer.","In dose escalation, any solid tumor patients with either O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation positivity on testing \u002F pre-screening of archival tissue OR an extracranial solid tumor where TMZ is considered a standard of care per National Comprehensive Cancer Network (NCCN) guidelines (neuroendocrine tumor, small cell lung cancer, melanoma or soft tissue sarcoma). The tumor lesion must be safely accessible to a mandatory biopsy. Patients with MGMT promoter hypermethylated colorectal cancer must be mismatch repair proficient \u002F microsatellite stable.","In phase 2, only patients with mismatch repair proficient \u002F microsatellite stable colorectal cancer that have MGMT promoter hypermethylation positivity on pre-screening of archival tissue will be eligible.","In dose escalation, patients must have progressed after treatment with all available therapies including immunotherapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Patients may not have previously received temozolomide or an ataxia telangiectasia and rad3-related (ATR) inhibitor.","For patients with mismatch repair proficient \u002F microsatellite stable colorectal cancer in the phase 2 portion, patients must have received prior therapy with 1 or more systemic therapies in the metastatic setting that includes 5-fluorouracil, irinotecan, and oxaliplatin. Patients with microsatellite stable colorectal cancer (mCRC) need to have had exposure, unless contraindicated, to all 3 of oxaliplatin, irinotecan, and fluoropyrimidine (FP).","Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of M1774 in combination with temozolomide in patients \\\u003C 18 years of age, children are excluded from this study.","Measurable disease on CT and\u002For MRI per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.","Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%).","Hemoglobin \\>=10 g\u002FdL (No blood transfusions are allowed within 14 days of cycle 1 day 1 \\[C1D1\\]).","White blood cells (WBC) \\> 3 x 10\\^9\u002FL.","Absolute neutrophil count \\>= 1,500\u002FmcL.","Platelets \\>= 100,000\u002FmcL.","Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN).","Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine-aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN except for when liver metastases are present, in which case they must be =\\\u003C 5 x institutional ULN.","Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2.","Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.","For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.","Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.","Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for 4 weeks.","Patients 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.","Patients 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, patients should be class 2B or better.","The effects of M1774 on the developing human fetus are unknown. For this reason and because ATR inhibitors agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of M1774 administration. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of M1774 administration.","Ability to understand and the willingness to sign a written informed consent document.",[169,170,171,172,173,174,175,176,177],"Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia and neuropathy, which may be =\\\u003C grade 2.","History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to M1774 or temozolomide, including dacarbazine.","Patients with uncontrolled intercurrent illness.","Pregnant women are excluded from this study because M1774 is an ATR inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M1774 breastfeeding should be discontinued if the mother is treated with M1774. These potential risks also apply to temozolomide.","Patients with a prior history of ataxia telangiectasia.","Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication.","Patients who cannot discontinue proton-pump inhibitors (PPIs) while taking M1774. H-2 receptor antagonists are allowed but should not be taken within 12 hours before or 2 hours after M1774. Antacids are also allowed, but should not be taken 2 hours before 2 hours after M1774.","Extensive RT involving greater than 30% of the bone marrow is not permitted during the study.","A Fridericia's correction formula (QTcF) \\> 480 ms is exclusionary given the potential for QT.","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of metastatic advanced cancer.\n* In dose escalation, any solid tumor patients with either O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation positivity on testing \u002F pre-screening of archival tissue OR an extracranial solid tumor where TMZ is considered a standard of care per National Comprehensive Cancer Network (NCCN) guidelines (neuroendocrine tumor, small cell lung cancer, melanoma or soft tissue sarcoma). The tumor lesion must be safely accessible to a mandatory biopsy. Patients with MGMT promoter hypermethylated colorectal cancer must be mismatch repair proficient \u002F microsatellite stable.\n* In phase 2, only patients with mismatch repair proficient \u002F microsatellite stable colorectal cancer that have MGMT promoter hypermethylation positivity on pre-screening of archival tissue will be eligible.\n* In dose escalation, patients must have progressed after treatment with all available therapies including immunotherapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Patients may not have previously received temozolomide or an ataxia telangiectasia and rad3-related (ATR) inhibitor.\n* For patients with mismatch repair proficient \u002F microsatellite stable colorectal cancer in the phase 2 portion, patients must have received prior therapy with 1 or more systemic therapies in the metastatic setting that includes 5-fluorouracil, irinotecan, and oxaliplatin. Patients with microsatellite stable colorectal cancer (mCRC) need to have had exposure, unless contraindicated, to all 3 of oxaliplatin, irinotecan, and fluoropyrimidine (FP).\n\nThe use of 5-fluorouracil and oxaliplatin in the adjuvant setting is acceptable, provided the development of metastatic disease was less than 6 months after the completion of adjuvant therapy.\n\nPatients with a prior hypersensitivity reaction to oxaliplatin in the adjuvant setting do not require retreatment in the metastatic setting.\n\n* Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of M1774 in combination with temozolomide in patients \\\u003C 18 years of age, children are excluded from this study.\n* Measurable disease on CT and\u002For MRI per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%).\n* Hemoglobin \\>=10 g\u002FdL (No blood transfusions are allowed within 14 days of cycle 1 day 1 \\[C1D1\\]).\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL.\n* Absolute neutrophil count \\>= 1,500\u002FmcL.\n* Platelets \\>= 100,000\u002FmcL.\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine-aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN except for when liver metastases are present, in which case they must be =\\\u003C 5 x institutional ULN.\n* Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for 4 weeks.\n* Patients 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.\n* Patients 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, patients should be class 2B or better.\n* The effects of M1774 on the developing human fetus are unknown. For this reason and because ATR inhibitors agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of M1774 administration. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of M1774 administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia and neuropathy, which may be =\\\u003C grade 2.\n* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to M1774 or temozolomide, including dacarbazine.\n* Patients with uncontrolled intercurrent illness.\n* Pregnant women are excluded from this study because M1774 is an ATR inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M1774 breastfeeding should be discontinued if the mother is treated with M1774. These potential risks also apply to temozolomide.\n* Patients with a prior history of ataxia telangiectasia.\n* Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Patients who cannot discontinue proton-pump inhibitors (PPIs) while taking M1774. H-2 receptor antagonists are allowed but should not be taken within 12 hours before or 2 hours after M1774. Antacids are also allowed, but should not be taken 2 hours before 2 hours after M1774.\n* Extensive RT involving greater than 30% of the bone marrow is not permitted during the study.\n* A Fridericia's correction formula (QTcF) \\> 480 ms is exclusionary given the potential for QT.",[180,181],"ADULT","OLDER_ADULT",[183,201,209,219,233,243,251,265,275,285,292,301,314,322,329,338,348,356,363,367,371,385,398],{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":188,"contacts":189,"geoPoint":198},"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","Irvine","California","92612","United States",[190,195],{"name":191,"role":192,"phone":193,"email":194},"Site Public Contact","CONTACT","877-827-8839","ucstudy@uci.edu",{"name":196,"role":197},"Farshid Dayyani","PRINCIPAL_INVESTIGATOR",{"lat":199,"lon":200},33.66946,-117.82311,{"facility":202,"status":203,"city":204,"state":186,"zip":205,"country":188,"geoPoint":206},"UC San Diego Moores Cancer Center","ACTIVE_NOT_RECRUITING","La Jolla","92093",{"lat":207,"lon":208},32.84727,-117.2742,{"facility":210,"status":8,"city":211,"state":186,"zip":212,"country":188,"contacts":213,"geoPoint":216},"UC Irvine Health\u002FChao Family Comprehensive Cancer Center","Orange","92868",[214,215],{"name":191,"role":192,"phone":193,"email":194},{"name":196,"role":197},{"lat":217,"lon":218},33.78779,-117.85311,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":188,"contacts":224,"geoPoint":230},"Yale University","New Haven","Connecticut","06520",[225,228],{"name":191,"role":192,"phone":226,"email":227},"203-785-5702","canceranswers@yale.edu",{"name":229,"role":197},"Michael Cecchini",{"lat":231,"lon":232},41.30815,-72.92816,{"facility":234,"status":8,"city":235,"state":222,"zip":236,"country":188,"contacts":237,"geoPoint":240},"Smilow Cancer Hospital Care Center-Trumbull","Trumbull","06611",[238,239],{"name":191,"role":192,"phone":226,"email":227},{"name":229,"role":197},{"lat":241,"lon":242},41.24287,-73.20067,{"facility":244,"status":203,"city":245,"state":246,"zip":247,"country":188,"geoPoint":248},"Memorial Hospital East","Shiloh","Illinois","62269",{"lat":249,"lon":250},38.56144,-89.89732,{"facility":252,"status":8,"city":253,"state":254,"zip":255,"country":188,"contacts":256,"geoPoint":262},"University of Kansas Clinical Research Center","Fairway","Kansas","66205",[257,260],{"name":191,"role":192,"phone":258,"email":259},"913-588-3671","KUCC_Navigation@kumc.edu",{"name":261,"role":197},"Raed Al-Rajabi",{"lat":263,"lon":264},39.02223,-94.6319,{"facility":266,"status":8,"city":267,"state":254,"zip":268,"country":188,"contacts":269,"geoPoint":272},"University of Kansas Cancer Center","Kansas City","66160",[270,271],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":273,"lon":274},39.11417,-94.62746,{"facility":276,"status":8,"city":277,"state":254,"zip":278,"country":188,"contacts":279,"geoPoint":282},"University of Kansas Cancer Center-Overland Park","Overland Park","66210",[280,281],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":283,"lon":284},38.98223,-94.67079,{"facility":286,"status":8,"city":277,"state":254,"zip":287,"country":188,"contacts":288,"geoPoint":291},"University of Kansas Hospital-Indian Creek Campus","66211",[289,290],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":283,"lon":284},{"facility":293,"status":8,"city":294,"state":254,"zip":255,"country":188,"contacts":295,"geoPoint":298},"University of Kansas Hospital-Westwood Cancer Center","Westwood",[296,297],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":299,"lon":300},39.04056,-94.6169,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":188,"contacts":306,"geoPoint":311},"National Cancer Institute Developmental Therapeutics Clinic","Bethesda","Maryland","20892",[307,309],{"name":191,"role":192,"phone":308},"800-411-1222",{"name":310,"role":197},"A P. Chen",{"lat":312,"lon":313},38.98067,-77.10026,{"facility":315,"status":203,"city":316,"state":317,"zip":318,"country":188,"geoPoint":319},"Siteman Cancer Center at Saint Peters Hospital","City of Saint Peters","Missouri","63376",{"lat":320,"lon":321},38.80033,-90.62651,{"facility":323,"status":203,"city":324,"state":317,"zip":325,"country":188,"geoPoint":326},"Siteman Cancer Center at West County Hospital","Creve Coeur","63141",{"lat":327,"lon":328},38.66089,-90.42262,{"facility":330,"status":8,"city":267,"state":317,"zip":331,"country":188,"contacts":332,"geoPoint":335},"University of Kansas Cancer Center - North","64154",[333,334],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":336,"lon":337},39.09973,-94.57857,{"facility":339,"status":8,"city":340,"state":317,"zip":341,"country":188,"contacts":342,"geoPoint":345},"University of Kansas Cancer Center - Lee's Summit","Lee's Summit","64064",[343,344],{"name":191,"role":192,"phone":258,"email":259},{"name":261,"role":197},{"lat":346,"lon":347},38.91084,-94.38217,{"facility":349,"status":350,"city":351,"state":317,"zip":352,"country":188,"geoPoint":353},"University of Kansas Cancer Center at North Kansas City Hospital","SUSPENDED","North Kansas City","64116",{"lat":354,"lon":355},39.13,-94.56218,{"facility":357,"status":203,"city":358,"state":317,"zip":359,"country":188,"geoPoint":360},"Washington University School of Medicine","St Louis","63110",{"lat":361,"lon":362},38.62727,-90.19789,{"facility":364,"status":203,"city":358,"state":317,"zip":365,"country":188,"geoPoint":366},"Siteman Cancer Center-South County","63129",{"lat":361,"lon":362},{"facility":368,"status":203,"city":358,"state":317,"zip":369,"country":188,"geoPoint":370},"Siteman Cancer Center at Christian Hospital","63136",{"lat":361,"lon":362},{"facility":372,"status":8,"city":373,"state":374,"zip":375,"country":188,"contacts":376,"geoPoint":382},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",[377,380],{"name":191,"role":192,"phone":378,"email":379},"405-271-8777","ou-clinical-trials@ouhsc.edu",{"name":381,"role":197},"Abdul Rafeh Naqash",{"lat":383,"lon":384},35.46756,-97.51643,{"facility":386,"status":8,"city":387,"state":388,"zip":389,"country":188,"contacts":390,"geoPoint":395},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",[391,393],{"name":191,"role":192,"phone":392},"412-647-8073",{"name":394,"role":197},"Janie Y. Zhang",{"lat":396,"lon":397},40.44062,-79.99589,{"facility":399,"status":8,"city":400,"state":401,"zip":402,"country":188,"contacts":403,"geoPoint":408},"Vanderbilt University\u002FIngram Cancer Center","Nashville","Tennessee","37232",[404,406],{"name":191,"role":192,"phone":405},"800-811-8480",{"name":407,"role":197},"Elizabeth J. Davis",{"lat":409,"lon":410},36.16589,-86.78444,[],[413],{"name":229,"affiliation":414,"role":197},"Yale University Cancer Center LAO",[],[],{"nct_id":4,"conditions":418,"biomarkers":421},[419,21,420],"Colorectal Carcinoma","Solid Neoplasm",[422],"MGMT Gene",{"nct_id":4,"found":424,"summary":425,"prompt_version":435},true,{"design":426,"status":427,"heading":428,"summary":429,"follow_up":430,"word_count":431,"commitments":432,"compensation":433,"drugs_mentioned":434},"This is a Phase I\u002FII interventional study, meaning it tests the safety and effectiveness of a new treatment. It plans to enroll about 42 participants.","completed","Testing Temozolomide and M1774 for Advanced Cancers","This study is testing the combination of two anti-cancer drugs, Temozolomide and M1774, to see if they are safe and effective for people with advanced cancer that has spread to other parts of the body. Temozolomide works by damaging cancer cell DNA, which can kill cells or stop their growth. M1774 may also stop cancer growth by blocking enzymes needed for cells to grow. Researchers hope that combining these drugs will shrink or stabilize cancer more effectively than Temozolomide alone. The study is looking for about 42 participants aged 18 and older with advanced metastatic cancer. For some participants, a specific biomarker (O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation) in their tumor tissue is required for eligibility. The main goal is to find the highest safe dose of the drug combination. The current recruitment status is unclear.","The primary safety endpoint (dose limiting toxicity and maximum tolerated dose) is measured for up to 28 days.",136,"You would receive M1774 orally once daily for 7 days and Temozolomide orally once daily for 5 days, repeating every 28 days. You would also undergo biopsy procedures, blood sample collections, CT scans, and MRI scans.","Not stated in the trial record.",[94],"v2"]