Prueba de la adición de un medicamento contra el cáncer, BAY 1895344, a la quimioterapia habitual para tumores sólidos en etapa avanzada, con un enfoque específico en pacientes con cáncer de pulmón de células pequeñas, cáncer neuroendocrino pobremente diferenciado y cáncer de páncreas
BAY 1895344 más inhibidores de topoisomerasa-1 (Top1) en pacientes con tumores sólidos avanzados, estudios de fase I con cohortes de expansión en carcinoma de pulmón de células pequeñas (SCLC), carcinoma neuroendocrino pobremente diferenciado (PD-NEC) y adenocarcinoma pancreático (PDA)
This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.
Descripción general del estudio
Estado
Condiciones
- Cáncer de páncreas en estadio III AJCC v8
- Cáncer de páncreas en estadio IV AJCC v8
- Adenocarcinoma de páncreas metastásico
- Cáncer de pulmón en estadio III AJCC v8
- Cáncer de pulmón en estadio IV AJCC v8
- Neoplasia sólida maligna irresecable
- Neoplasia sólida maligna metastásica
- Adenocarcinoma de páncreas irresecable
- Carcinoma de células pequeñas de pulmón metastásico
- Carcinoma neuroendocrino metastásico
- Carcinoma de células pequeñas de pulmón irresecable
- Carcinoma neuroendocrino irresecable
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess safety and tolerability of each of the elimusertib (BAY 1895344) plus topoisomerase 1 (top1) inhibitor (irinotecan hydrochloride [irinotecan] or topotecan hydrochloride [topotecan]) combinations.
II. To estimate maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of each of the combinations.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To estimate objective response rate (ORR), progression free survival (PFS), overall survival (OS) and duration of response (DOR) in patients treated with each combination.
III. To estimate plasma pharmacokinetic (PK) characteristics of BAY 1895344 plus each top1 inhibitor (irinotecan or topotecan) when used in combination.
IV. To estimate changes in pharmacodynamic (PD) markers of deoxyribonucleic acid (DNA) damage (gamma-H2AX, phosphorylated [p]S343-NBS1) elicited by each combination from on-treatment tumor biopsies (in dose expansion cohorts only).
EXPLORATORY OBJECTIVES:
I. To estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ataxia telangiectasia mutated (ATM) expression loss (assessed by immunohistochemistry [IHC]).
II. To estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumor DNA damage response (DDR) mutations (assessed by whole exome sequencing [WES], ribonucleic acid [RNA] sequencing [RNA Seq], and circulating tumor DNA [ctDNA] analysis).
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 cohorts.
COHORT I: Patients receive elimusertib orally (PO) twice daily (BID) on days 1 and 2 and irinotecan intravenously (IV) over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
COHORT II: Patients receive elimusertib PO once daily (QD) on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
COHORT III: Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
After completion of study treatment, patients are followed every 2 months for up to 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic Hospital in Arizona
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California
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Orange, California, Estados Unidos, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Trumbull, Connecticut, Estados Unidos, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-9980
- Mayo Clinic in Florida
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Kansas
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Fairway, Kansas, Estados Unidos, 66205
- University of Kansas Clinical Research Center
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Estados Unidos, 66210
- University of Kansas Cancer Center-Overland Park
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Overland Park, Kansas, Estados Unidos, 66211
- University of Kansas Hospital-Indian Creek Campus
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Missouri
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City of Saint Peters, Missouri, Estados Unidos, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Estados Unidos, 63141
- Siteman Cancer Center at West County Hospital
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Kansas City, Missouri, Estados Unidos, 64154
- University of Kansas Cancer Center - North
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Lee's Summit, Missouri, Estados Unidos, 64064
- University of Kansas Cancer Center - Lee's Summit
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North Kansas City, Missouri, Estados Unidos, 64116
- University of Kansas Cancer Center at North Kansas City Hospital
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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St Louis, Missouri, Estados Unidos, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Estados Unidos, 63136
- Siteman Cancer Center at Christian Hospital
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New York
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The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center-Einstein Campus
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- UPMC Hillman Cancer Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University/Ingram Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- DOSE ESCALATION COHORTS: Patients must have a biopsy-proven solid tumor that is metastatic or unresectable and has progressed on at least one line of standard therapy
- DOSE ESCALATION COHORTS: Patients must have a solid tumor for which irinotecan or topotecan is considered standard of care
- DOSE EXPANSION COHORTS: Patients must have biopsy proven metastatic or unresectable small cell lung cancer (SCLC), poorly differentiated neuroendocrine carcinoma (PD-NEC) (any extrapulmonary neuroendocrine carcinoma with small cell or large cell histology) or pancreatic adenocarcinoma (PDA) and have progressed on at least one line of standard therapy
- DOSE EXPANSION COHORTS: Patients must have at least one measurable lesion outside of the lesion to be biopsied
- Patients must be able to swallow pills
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 1895344 in combination with irinotecan or topotecan in patients < 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Hemoglobin > 9 g/dL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 x institutional ULN if liver metastases present)
- Glomerular filtration rate (GFR) >= 60 mL/min/1.73 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. Furthermore, these patients must be asymptomatic from previously treated brain metastases (e.g. not on steroids for neurologic symptoms within 30 days of study enrollment)
- 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 BAY 1895344 on the developing human fetus are unknown. For this reason and because DNA-damage response inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 6 months after completion of BAY 1895344 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 6 months after completion of BAY 1895344 administration
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion Criteria:
- Patients who have previously been treated with irinotecan will not be eligible to participate in the irinotecan arm and patients who have previously been treated with topotecan will not be eligible to participate in the topotecan arm. However, patients who previously received irinotecan may be treated with topotecan (and vice versa) should the other agent be considered a possible standard of care for their disease. Patients who have previously been treated with BAY 1895344 will be excluded from the study
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- 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 endocrinopathies from prior immunotherapy
- Patients who are receiving any other investigational agents
- The investigator(s) must state a medical or scientific reason if patients who have brain metastases will be excluded from the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 1895344 or other agents used in study
- Patients receiving any medications or substances that are substrates of CYP3A4 with a narrow therapeutic window, or strong inhibitors/inducers of CYP3A4 are ineligible, if they cannot be transferred to alternative medication. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because BAY 1895344 is 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 BAY 1895344, breastfeeding should be discontinued if the mother is treated with BAY 1895344. These potential risks may also apply to other agents used in this study
- Patients with an uncontrolled infection requiring IV antibiotics will not be eligible to participate in the study
- Patients on strong CYP3A4 inhibitors must discontinue them at least 1 week prior to starting irinotecan therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort I (elimusertib, irinotecan)
Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
Undergo CT
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Undergo MRI
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Undergo collection of blood samples
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Undergo tumor biopsy
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Given IV
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Given PO
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Experimental: Cohort II (elimusertib, irinotecan)
Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
Undergo CT
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Undergo MRI
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Undergo collection of blood samples
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Undergo tumor biopsy
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Given IV
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Given PO
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Experimental: Cohort III (elimusertib, topotecan)
Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
Undergo CT
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Undergo MRI
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Undergo collection of blood samples
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Undergo tumor biopsy
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Given IV
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Given PO
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib
Periodo de tiempo: Up to 21 days (first treatment cycle)
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Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. |
Up to 21 days (first treatment cycle)
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Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan
Periodo de tiempo: Up to 21 days (first treatment cycle)
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Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. |
Up to 21 days (first treatment cycle)
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Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan
Periodo de tiempo: Up to 21 days (first treatment cycle)
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Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. |
Up to 21 days (first treatment cycle)
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Occurrence of Grade 4 Hematologic AEs (Dose Expansion Phase)
Periodo de tiempo: Up to 6 months post-treatment
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Grade 4 hematologic toxicity will be monitored using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Clinical safety data (e.g. AEs) will be tabulated and summarized using descriptive statistics as requested by the sponsor investigator, executive committee, medical monitor or Data Safety Monitoring Board using methods described in the Data Safety Monitoring Plan. |
Up to 6 months post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective Response Rate (ORR)
Periodo de tiempo: Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR. |
Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment
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Duration of Response (DOR)
Periodo de tiempo: Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
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DOR will be estimated by the Kaplan-Meier method. Duration of response was calculated among patients with complete response, partial response, or stable disease. |
Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
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Progression-free Survival (PFS)
Periodo de tiempo: Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
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PFS will be estimated by the Kaplan-Meier method. |
Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
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Overall Survival (OS)
Periodo de tiempo: From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment
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OS will be estimated by the Kaplan-Meier method. |
From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment
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Maximum Concentration (Cmax) of Elimusertib
Periodo de tiempo: See above as time frames were different fore each dose cohort
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Estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion |
See above as time frames were different fore each dose cohort
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Area Under the Concentration-time Curve (AUC) for Elimusertib
Periodo de tiempo: See above as time frames are different for each dose cohort
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Will be estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion |
See above as time frames are different for each dose cohort
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Maximum Concentration (Cmax) of Irinotecan (Cohorts I and II)
Periodo de tiempo: See above as time frames were different for each cohort
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Estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose |
See above as time frames were different for each cohort
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Area Under the Concentration-time Curve (AUC) for Irinotecan
Periodo de tiempo: See above as time frames were different for each cohort
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Will be estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose |
See above as time frames were different for each cohort
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Maximum Concentration (Cmax) of Topotecan (Cohort III, TACs 7 and 14)
Periodo de tiempo: Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion
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Estimated for topotecan based upon plasma collections from cycle 1 in all study patients. |
Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion
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Area Under the Concentration-time Curve (AUC) for Topotecan
Periodo de tiempo: Cycle 1
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Will be estimated for topotecan based upon plasma collections from cycle 1 in all study patients. |
Cycle 1
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Changes in Tumor Expression Patterns of Gamma-H2AX
Periodo de tiempo: Baseline up to cycle 1, day 6
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Will be estimated for expansion cohort only study patients. |
Baseline up to cycle 1, day 6
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Changes in Tumor Expression Patterns of pS343-NBS1
Periodo de tiempo: Baseline up to cycle 1, day 6
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Will be estimated for expansion cohort only study patients. |
Baseline up to cycle 1, day 6
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tumor ATM Expression Loss
Periodo de tiempo: Baseline
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Will assess the prevalence of tumor ATM expression loss in all patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ATM expression loss. |
Baseline
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Tumor Deoxyribonucleic Acid Damage Response (DDR) Gene Mutations Present
Periodo de tiempo: Baseline
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Will assess the specific tumor DDR gene mutations present in study patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumors with DDR gene mutations. |
Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thatcher Heumann, Yale University Cancer Center LAO
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Procesos Neoplásicos
- Carcinoma
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Tumores neuroendocrinos
- Condiciones Patológicas, Signos y Síntomas
- Neoplasias Pulmonares
- Metástasis de neoplasias
- Neoplasias pancreáticas
- Carcinoma de pulmón de células pequeñas
- Carcinoma Neuroendocrino
- Compuestos heterocíclicos
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Técnicas citológicas
- Citodiagnóstico
- Campeptecina
- Alcaloides
- Técnicas de diagnóstico, quirúrgico
- Técnicas de química, analítica
- Análisis de espectro
- Irinotecán
- Topotecán
- Biopsia
- Manejo de muestras
- Espectroscopía de resonancia magnética
- Bahía 1895344
Otros números de identificación del estudio
- NCI-2020-05958
- UM1CA186689 (Subvención/contrato del NIH de EE. UU.)
- 10402 (Otro identificador: CTEP)
- NCI-2020-05958 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 10402 (Otro identificador: Yale University Cancer Center LAO)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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