A Study of LY2157299 in Participants With Hepatocellular Carcinoma
21 de diciembre de 2020 actualizado por: Eli Lilly and Company
Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma
The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study consists of four Parts: Part A where HCC participants with an increased alpha-fetoprotein (AFP) level will be treated with either 160 milligrams (mg) LY2157299 or 300 mg LY2157299. Part B where HCC participants with a normal AFP level will be treated with 300 mg LY2157299, Part C where treatment-naïve HCC participants will be treated with 160 mg LY2157299 + sorafenib or 300 mg LY2157299 + sorafenib, and Part D where HCC participants will be treated with either 160 mg or 300 mg LY2157299 + ramucirumab.
Participants who continue to receive benefit from treatment at the time that the study is considered completed, may enter the treatment extension period and continue to receive the study treatment. The end of the study is the date of last visit or last scheduled procedure for the last active subject in the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
204
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13353
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Erlangen, Alemania, 91054
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Göttingen, Alemania, 37075
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Köln, Alemania, 50937
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Mainz, Alemania, 55131
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Münster, Alemania, 48149
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Greenslopes, Australia, 4120
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Heidelberg, Australia, 3084
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St. Leonards, Australia, 2065
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Barcelona, España, 08035
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Madrid, España, 28007
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
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California
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San Francisco, California, Estados Unidos, 94158
- University of California, San Francisco
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Georgetown University Medical Center
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Florida
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Orlando, Florida, Estados Unidos, 32806
- MD Anderson Cancer Center Orlando
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana Univ Melvin & Bren Simon Cancer Center
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Massachusetts
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Burlington, Massachusetts, Estados Unidos, 01805
- Lahey Clinic Medical Center
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Estados Unidos, 10021
- Weill Cornell Medical College
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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Brest, Francia, 29609
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Caen, Francia, 14033
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Clichy, Francia, 92110
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Creteil, Francia, 94010
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Lille, Francia, 59037
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Lyon, Francia, 69317
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Marseille, Francia, 13273
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Montpellier, Francia, 34295
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Paris, Francia, 75012
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Pessac, Francia, 33604
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Saint Etienne, Francia, 42055
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Saint Herblain, Francia, 44805
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Strasbourg, Francia, 67085
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Vandoeuvre Les Nancy, Francia, 54511
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Bari, Italia, 70124
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Rome, Italia, 00168
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Rozzano, Italia, 20089
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Auckland, Nueva Zelanda, 1023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Have histological evidence of a diagnosis of HCC not amenable to curative surgery
- Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D
- Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
- Have given written informed consent prior to any study-specific procedures
- Have adequate hematologic, hepatic and renal function
- Have a performance status of equal to or less than 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- For Parts A & B: Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment. For Part C: not received previous systemic treatment. For Part D: have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment or have not received prior systemic treatment.
- For Parts A, B, and D: have discontinued sorafenib for at least 2 weeks
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
- Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
- Are able to swallow capsules or tablets
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Known HCC with fibro-lamellar or mixed histology
- Presence of clinically relevant ascites
- History of liver transplant requiring increased immunosuppressive therapy. (Participants on maintenance immunosuppressive therapy after liver transplant are eligible for Part A & B)
- Have received more than 1 line of systemic treatment in Parts A, B and D
Have moderate or severe cardiac disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
- Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
- Have major abnormalities documented by echocardiography with Doppler
- Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
- Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
- Females who are pregnant or lactating
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years. At the discretion of the investigator, hormone-refractory prostate cancer participants who are stable on GnRH agonist therapy and breast cancer participants who are stable on antiestrogen therapy may have that treatment continued
- Have active infection that would interfere with the study objectives or influence study compliance
- For Part C, have a known hypersensitivity to sorafenib or its excipients
For Part D, have a serious illness or medical condition(s), including but not limited to the following:
- The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization
- The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury (mm Hg) despite standard medical management
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Part A Cohort 1-160 milligram (mg) LY2157299
Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm. As of May 25,2012, all newly enrolled participants will receive 300 mg LY2157299. 80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
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Experimental: Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
Administrado por vía oral
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Experimental: Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
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Experimental: Part C Cohort 1 - 160 mg LY2157299 + 800 mg Sorafenib
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
Administrado por vía oral
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Experimental: Part C Cohort 2 - 300 mg LY2157299 + 800 mg Sorafenib
150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
Administrado por vía oral
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Experimental: Part D Cohort 1 - 160 mg LY2157299 + 8 mg/kg Ramucirumab
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
IV administrado
Otros nombres:
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Experimental: Part D Cohort 2 - 300 mg LY2157299 + 8 mg/kg Ramucirumab
150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
Administrado por vía oral
IV administrado
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)
Periodo de tiempo: Baseline, discontinuation from any cause (Up to 83 months)
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Biomarker response was defined as a > 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment.
Data presented is median overall survival of those participants who achieved the defined biomarker response.
Participants enrolled in Part A had a baseline AFP level of >1.5 upper limit normal (ULN).
Participants enrolled in Part B had baseline AFP level <1.5 ULN.
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Baseline, discontinuation from any cause (Up to 83 months)
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Change From Baseline in Relationship of Biomarker Transforming Growth Factor - Beta (TGF-β) to Overall Survival (OS)
Periodo de tiempo: Baseline,discontinuation from any cause (Up to 83 months)
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Biomarker response was defined as a > 20% decrease in the biomarker TGF-B from baseline.
Data presented is median overall survival of those participants who achieved biomarker response.
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Baseline,discontinuation from any cause (Up to 83 months)
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Time to Progression (TTP)
Periodo de tiempo: Randomization to date of first measured progressive disease (Up to 36 Weeks)
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TTP is measured from the date of first dose to the first date of progression of disease based on the investigator review of tumor response using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
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Randomization to date of first measured progressive disease (Up to 36 Weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib
Periodo de tiempo: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1
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Population mean (between-subject coefficient variance [CV %]) apparent clearance.
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Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1
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Recommended Dose for Phase 3 Hepatocellular Carcinoma (HCC) Trials
Periodo de tiempo: Cycle 1 (28 Days)
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Cycle 1 (28 Days)
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Overall Survival (OS)
Periodo de tiempo: Randomization to date of death from any cause (Up to 83 months)
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OS duration is measured from the date of first dose to the date of death from any cause.
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Randomization to date of death from any cause (Up to 83 months)
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Progression Free Survival (PFS)
Periodo de tiempo: Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
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PFS duration is measure from the date of first dose to the first date of objective progression of disease or death from any cause.
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
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Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
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Percentage of Participants Achieving an Objective Response (Response Rate)
Periodo de tiempo: Randomization to measured progressive disease (Up to 36 Weeks)
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The percentage of participants who achieved best overall response of either Complete Response (CR) or Partial Response (PR).
The overall response rate for each dose with be estimated by dividing the number of confirmed responders by the number of participants who received at least one dose of study drug.
Per RECIST v.1.0
criteria CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm).
Tumor-marker results must have normalized.
PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
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Randomization to measured progressive disease (Up to 36 Weeks)
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Duration of Tumor Response (DoR)
Periodo de tiempo: Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
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DoR is measured from the date of the first objective status assessment of a Complete Response (CR) or Partial Response (PR), as determined by RECIST v1.1, to the first date of objective progression of disease or death from any cause.
CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm).
Tumor-marker results must have normalized.
PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
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Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
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Time to Treatment Failure (TTF)
Periodo de tiempo: Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
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TTF is measured from the date of first dose until the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause.
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Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
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Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score
Periodo de tiempo: Baseline, Day 1 Cycle 4
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FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72; FACT-Hep score range 1-180, and Trial-Outcome Index (TOI) score range 1-128, to assess health related quality of life in participants with cancer.
Higher scores reflect a better health state.
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Baseline, Day 1 Cycle 4
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Time to Worsening (TTW) of Symptoms (FACT-Hep)
Periodo de tiempo: Baseline to the worsening of symptoms (up to 567 days)
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Time to worsening of symptoms used minimally important differences to evaluate Physical Well Being (PWB), Functional Well Being (FWB), Hepatocellular Cancer Symptoms (HCS), National Comprehensive Cancer Network (NCCN)/FACT Hepatocellular Symptoms (FHS), Trial-Outcome Index (TOI).
PWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; FWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; HCS time to worsening was defined as participants who had change in a subscale of ≥ 5 point decrease from baseline; FHS time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; TOI time to Worsening was defined as participants who had change in the subscale of ≥ 7 point decrease from baseline.
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Baseline to the worsening of symptoms (up to 567 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Giannelli G, Santoro A, Kelley RK, Gane E, Paradis V, Cleverly A, Smith C, Estrem ST, Man M, Wang S, Lahn MM, Raymond E, Benhadji KA, Faivre S. Biomarkers and overall survival in patients with advanced hepatocellular carcinoma treated with TGF-betaRI inhibitor galunisertib. PLoS One. 2020 Mar 25;15(3):e0222259. doi: 10.1371/journal.pone.0222259. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235580. PLoS One. 2021 Jun 17;16(6):e0253671.
- Addepalli A, Kalyani S, Singh M, Bandyopadhyay D, Mohan KN. CalPen (Calculator of Penetrance), a web-based tool to estimate penetrance in complex genetic disorders. PLoS One. 2020 Jan 29;15(1):e0228156. doi: 10.1371/journal.pone.0228156. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235547.
- Faivre S, Santoro A, Kelley RK, Gane E, Costentin CE, Gueorguieva I, Smith C, Cleverly A, Lahn MM, Raymond E, Benhadji KA, Giannelli G. Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma. Liver Int. 2019 Aug;39(8):1468-1477. doi: 10.1111/liv.14113. Epub 2019 Jun 3.
- Li S, Yang F, Ren X. Immunotherapy for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):363-71. doi: 10.5582/ddt.2015.01054.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de marzo de 2011
Finalización primaria (Actual)
6 de junio de 2019
Finalización del estudio (Actual)
24 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
1 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
23 de noviembre de 2010
Publicado por primera vez (Estimar)
24 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
21 de diciembre de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Sorafenib
- Ramucirumab
Otros números de identificación del estudio
- 13665
- H9H-MC-JBAK (Otro identificador: Eli Lilly and Company)
- 2010-022338-10 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Marco de tiempo para compartir IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .