- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02049957
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The drug being tested in this study is called sapanisertib (MLN0128). Sapanisertib is being tested in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus. This study will look at the safety and efficacy of sapanisertib when given in combination with exemestane or fulvestrant.
The study enrolled 118 patients. This study has two phases: phase 1 and phase 2. Phase 1 has 2 parts. In part 1 of phase 1, unmilled active pharmaceutical ingredient (API) capsules were administered, while in part 2, capsules based on milled API were administered.
- Phase 1 (Part 1): sapanisertib 5 mg (unmilled) + exemestane
- Phase 1 (Part 1): sapanisertib 5 mg (unmilled) + fulvestrant
- Phase 1 (Part 2): sapanisertib 3 mg (milled) + exemestane
- Phase 1 (Part 2): sapanisertib 3 mg (milled) + fulvestrant
- Phase 1 (Part 2): sapanisertib 4 mg (milled) + exemestane
In phase 2, participants were enrolled into one of 2 parallel cohorts, depending on the quality and/or duration of their prior response to everolimus in combination with either exemestane (any country) or fulvestrant (US only).
Everolimus-Resistant Cohort: patients who had progressed on treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) without achieving an objective response (CR or PR) or after achieving stable disease for <6 months as their best response.
Everolimus-Sensitive Cohort: participants who had progressed on treatment after achieving a CR or PR of any duration, or stable disease for ≥6 months with prior everolimus treatment in combination with either exemestane (any country) or fulvestrant (US only). Participants were to receive MLN0128 in combination with the same dose of the previously administered treatment (exemestane [any country] or fulvestrant [US only]).
This multi-center trial will be conducted worldwide. The overall time to participate in this study was 52 months. Participants made multiple visits to the clinic and were contacted by telephone every 3 months for a follow-up assessment.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Antwerpen, Belgia, 2650
- UZ Antwerpen
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Bruxelles, Belgia, 1000
- Institut Jules Bordet
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Bruxelles, Belgia, 1090
- Universitair Ziekenhuis Brussel
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Charleroi, Belgia, 6000
- GHdC Notre Dame
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Libramont, Belgia, 6800
- Centre Hospitalier de l'Ardenne
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Wilrijk, Belgia, 2610
- GZA Ziekenhuizen - Campus Sint-Augustinus
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Calvados
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Caen Cedex 05, Calvados, Francja, 14076
- Centre François Baclesse
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Loire Atlantique
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Nantes, Loire Atlantique, Francja, 44202
- Centre Catherine de Sienne
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Sarthe
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Le Mans Cedex 02, Sarthe, Francja, 72015
- Clinique Victor Hugo - Centre Jean Bernard
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Vaculuse
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Avignon, Vaculuse, Francja, 84000
- Institut Sainte Catherine
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California
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Los Angeles, California, Stany Zjednoczone, 90017
- Los Angeles Hematology
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San Francisco, California, Stany Zjednoczone, 94143
- University of California at San Francisco (PARENT)
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Santa Barbara, California, Stany Zjednoczone, 93105
- Santa Barbara Hematology Oncology Medical Group, Inc.
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- University Of Colorado Cancer Center
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Lakewood, Colorado, Stany Zjednoczone, 80228
- Rocky Mountain Cancer Centers, LLP
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Florida
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Miami Beach, Florida, Stany Zjednoczone, 33140
- Mount Sinai Medical Center
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Plantation, Florida, Stany Zjednoczone, 33324
- Florida Cancer Research Institute
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Kansas
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Westwood, Kansas, Stany Zjednoczone, 66205
- University of Kansas Medical Center Research Institute, Inc.
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Maryland
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Silver Spring, Maryland, Stany Zjednoczone, 20910
- Holy Cross Hospital
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Michigan
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Novi, Michigan, Stany Zjednoczone, 48322
- Henry Ford Medical Center
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic
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New York
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Bronx, New York, Stany Zjednoczone, 10469
- Eastchester Center for Cancer Care / BRANY
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Buffalo, New York, Stany Zjednoczone, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Stany Zjednoczone, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, Stany Zjednoczone, 10065
- Weill Cornell Medical College New York Presbyterian Hospital
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45267-0502
- University of Cincinnati Physicians Company, LLC
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Cleveland, Ohio, Stany Zjednoczone, 44106
- University Hospitals of Cleveland
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Tennessee
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Chattanooga, Tennessee, Stany Zjednoczone, 37403
- Erlanger Medical Center
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Texas
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Beaumont, Texas, Stany Zjednoczone, 77702-1449
- Texas Oncology, P.A. - Beaumont
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Dallas, Texas, Stany Zjednoczone, 75246
- Texas Oncology, P.A.
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Dallas, Texas, Stany Zjednoczone, 75390-9085
- UT Southwestern Medical Center
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Houston, Texas, Stany Zjednoczone, 77030
- The University of Texas MD Anderson Cancer Center
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Houston, Texas, Stany Zjednoczone, 77090
- Millennium Oncology
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Plano, Texas, Stany Zjednoczone, 75093
- Texas Health Physicians Group
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San Antonio, Texas, Stany Zjednoczone, 78217
- Cancer Care Network of South Texas - SAT&BC
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Tyler, Texas, Stany Zjednoczone, 75702
- Texas Oncology, P.A. - Tyler
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Virginia
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Chesapeake, Virginia, Stany Zjednoczone, 23320
- Virginia Oncology Associates - Hampton
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Salem, Virginia, Stany Zjednoczone, 24153
- Oncology and Hematology Assoc. of SW VA, Inc.
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West Virginia
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Morgantown, West Virginia, Stany Zjednoczone, 26506
- West Virginia University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Phase 1b and Phase 2
- Advanced or metastatic breast cancer.
- Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor cells), and histological or cytological confirmation of HER2-negative (HER2-) status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.
Female patients 18 years of age or older who are postmenopausal for at least 1 year before the Screening visit, where menopause is defined by: Age ≥ 55 years and 1 year or more of amenorrhea. Surgical menopause with bilateral oophorectomy
Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL
Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.
Have a history of brain metastasis are eligible for the study provided that all the following criteria are met:
Brain metastases which have been treated
- No evidence of disease progression for ≥ 3 months or hemorrhage after treatment
- Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128
- No ongoing requirement for dexamethasone or anti-epileptic drugs
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Clinical laboratory values as specified below within 4 weeks before the first dose of MLN0128:
- Bone marrow reserve consistent with absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present)
- Creatinine clearance ≥ 50 mL/min based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection
- Fasting serum glucose ≤ 130 mg/dL and fasting triglycerides ≤ 300 mg/dL
- Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible for the study).
- Able to provide paraffin blocks or a minimum of 10 unstained slides of available archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is not available, a tumor biopsy may be performed before the patient begins treatment with MLN0128. If fewer than 10 slides are available or the tumor content/area requirements are not met, study eligibility will be determined upon discussion with the sponsor.
- Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.
Voluntary written consent must be given before the performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Phase 1b Only: In addition to the previously mentioned inclusion criteria, each patient must meet the following inclusion criterion to be enrolled in the phase 1b portion of the study:
Patients may have SD or disease progression during their most recent treatment with exemestane or fulvestrant, or everolimus in combination with either exemestane (any country) or fulvestrant (US only). Exemestane or fulvestrant in combination with MLN0128 can also be initiated as a new line of therapy.
Phase 2 Only: In addition to the previously mentioned inclusion criteria, each patient must meet all of the following inclusion criteria to be enrolled in the phase 2 portion of the study:
Measurable disease defined as follows:
- At least 1 extra-osseous lesion that can be accurately measured in at least 1 dimension. The lesion must measure ≥ 20 mm with conventional imaging techniques or ≥ 10 mm with spiral computed tomography (CT) or magnetic resonance imaging (MRI), or
- Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above
- Patients must have had disease progression during treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) (duration of treatment ≥ 4 weeks) and must have tolerated everolimus treatment in combination with exemestane (any country) or fulvestrant (US only) adequately according to the treating physician's judgment. Everolimus in combination with exemestane or fulvestrant is not required to be the most recent treatment before enrollment, but progression on the most recent anticancer therapy is required for enrollment.
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Phase 1b and Phase 2
- Prior anticancer therapy or other investigational therapy within 2 weeks before administration of the first dose of MLN0128 (except for exemestane or fulvestrant, which should be continued). Treatment with everolimus must be discontinued 2 weeks before administration of the first dose of MLN0128.
- Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of bone metastases. Concomitant treatment with bisphosphonates or denosumab is permitted for treatment of osteoporosis or management of existing bone metastases if initiated at least 4 weeks before administration of the first dose of MLN0128.
- Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of MLN0128 (patients already receiving erythropoietin on a chronic basis for ≥ 4 weeks are eligible).
- Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors.
- Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128.
- Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met.
- Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study.
- Known human immunodeficiency virus infection.
History of any of the following within the last 6 months before administration of the first dose of MLN0128:
- Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
- Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures
- Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)
- Placement of a pacemaker for control of rhythm
- New York Heart Association Class III or IV heart failure
- Pulmonary embolism
Significant active cardiovascular or pulmonary disease before administration of the first dose of MLN0128, including:
- Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic blood pressure > 95 mm Hg)
- Pulmonary hypertension
- Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air
- Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement
- Medically significant (symptomatic) bradycardia
- History of arrhythmia requiring an implantable cardiac defibrillator
- Baseline prolongation of the rate-corrected QT interval (QTc; eg, repeated demonstration of QTc interval > 480 ms, or history of congenital long QT syndrome, or torsades de pointes)
Diagnosed or treated for another malignancy within 2 years before administration of the first dose of MLN0128 or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Phase 1b Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 1b portion of the study:
More than 3 prior chemotherapy regimens for locally advanced or metastatic disease.
Phase 2 Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 2 portion of the study:
- More than 1 prior chemotherapy regimen for locally advanced or metastatic disease.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: LECZENIE
- Przydział: NIE_RANDOMIZOWANE
- Model interwencyjny: RÓWNOLEGŁY
- Maskowanie: NIC
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
EKSPERYMENTALNY: Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane
Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).
|
Sapnisertib capsules
Inne nazwy:
Exemestane tablets.
|
EKSPERYMENTALNY: Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant
Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).
|
Wstrzyknięcie fulwestrantu domięśniowo.
Sapnisertib capsules
Inne nazwy:
|
EKSPERYMENTALNY: Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane
Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 8 cycles).
|
Sapnisertib capsules
Inne nazwy:
Exemestane tablets.
|
EKSPERYMENTALNY: Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant
Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle up to 14 cycles plus fulvestrant 500 mg, injection, IM, once on Day 1 of each cycle (Up to 14 cycles).
|
Wstrzyknięcie fulwestrantu domięśniowo.
Sapnisertib capsules
Inne nazwy:
|
EKSPERYMENTALNY: Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane
Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 18 cycles).
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Sapnisertib capsules
Inne nazwy:
Exemestane tablets.
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EKSPERYMENTALNY: Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)
Sapanisertib 4 mg, zmielona kapsułka API raz dziennie w cyklu 28-dniowym plus eksemestan 25 mg, tabletki, raz dziennie w cyklu 28-dniowym (do 14 cykli) u uczestników wrażliwych na ewerolimus.
|
Sapnisertib capsules
Inne nazwy:
Exemestane tablets.
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EKSPERYMENTALNY: Phase 2:Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)
Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 17 cycles) in everolimus sensitive participants.
|
Wstrzyknięcie fulwestrantu domięśniowo.
Sapnisertib capsules
Inne nazwy:
|
EKSPERYMENTALNY: Phase 2: Sapanisertib 4 mg+Exemestane (Everolimus Resistant)
Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus once daily in a 28-day cycle (Up to 12 cycles) in everolimus resistant participants.
|
Sapnisertib capsules
Inne nazwy:
Exemestane tablets.
|
EKSPERYMENTALNY: Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)
Sapanisertib 4 mg, zmielona kapsułka API, raz dziennie w 28-dniowym cyklu plus fulwestrant 500 mg, wstrzyknięcie domięśniowe, raz w 1. dniu każdego cyklu (do 9 cykli) u uczestników opornych na ewerolimus.
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Wstrzyknięcie fulwestrantu domięśniowo.
Sapnisertib capsules
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: First dose of study drug through 30 days after the last dose (Up to 52 months)
|
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator. |
First dose of study drug through 30 days after the last dose (Up to 52 months)
|
Phase 2: Clinical Benefit Rate at 16 Weeks (CBR-16)
Ramy czasowe: Week 16
|
CBR-16 was defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR) of any duration or had confirmed stable disease (SD) as best response and the first 2 or more post baseline scans had PR/SD and the duration of SD was >112 days.
Disease response was assessed for target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
CR is disappearance of all target lesions.
PR is >=30% decrease in the sum of the longest diameter of target lesions.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD).
|
Week 16
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Phase 2: Clinical Benefit Rate at 24 Weeks (CBR-24)
Ramy czasowe: Week 24
|
CBR-24 was defined as the percentage of participants who achieved confirmed CR or PR at any time or had confirmed SD as best response and the first 2 or more post baseline scans had PR/SD and the duration of stable disease was >168 days.
Disease response was assessed for target lesions by CT or MRI according to RECIST version 1.1 guidelines.
CR is disappearance of all target lesions.
PR is >=30% decrease in the sum of the longest diameter of target lesions.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
|
Week 24
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Phase 2: Overall Response Rate (ORR)
Ramy czasowe: Baseline then every 2 cycles from Cycles 2 through 6, and every 3 cycles thereafter in a 28-day cycle up to End of Treatment (EOT) (Up to 24 months)
|
ORR is defined as the percentage of participants with confirmed CR or PR as per RECIST version1.1 guidelines.
CR is disappearance of all target lesions.
PR is >=30% decrease in the sum of the longest diameter of target lesions.
|
Baseline then every 2 cycles from Cycles 2 through 6, and every 3 cycles thereafter in a 28-day cycle up to End of Treatment (EOT) (Up to 24 months)
|
Phase 2: Progression-Free Survival (PFS)
Ramy czasowe: Wartość wyjściowa następnie co 2 cykle od cykli 2 do 6, a następnie co 3 cykle w cyklu 28-dniowym, następnie co 3 miesiące po EOT do progresji choroby lub zgonu (do 24 miesięcy)
|
PFS is defined as the time in months from the date of first dose of study treatment to the date of the first documented disease progression or death.
Disease progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; or the appearance of one or more new lesions.
|
Wartość wyjściowa następnie co 2 cykle od cykli 2 do 6, a następnie co 3 cykle w cyklu 28-dniowym, następnie co 3 miesiące po EOT do progresji choroby lub zgonu (do 24 miesięcy)
|
Phase 2: Overall Survival (OS)
Ramy czasowe: Up to 24 months
|
OS is the time in months from start of study treatment to date of death due to any cause.
Data for the analysis of OS included the censored data at the timepoint that the participant was last known to be alive.
|
Up to 24 months
|
Phase 2: Best Percent Change From Baseline in Tumor Size
Ramy czasowe: Baseline to Month 24
|
Baseline to Month 24
|
|
Phase1: Cmax: Maximum Observed Plasma Concentration for Sapanisertib
Ramy czasowe: Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose
|
Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose
|
|
Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Sapanisertib
Ramy czasowe: Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose
|
Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose
|
|
Phase 1: AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Sapanisertib
Ramy czasowe: Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to 24 hours post-dose
|
AUC(0-24) is the area under the plasma concentration-time curve of the samples collected up to 8 hours and extrapolated up to 24 hours.
|
Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to 24 hours post-dose
|
Phase 1: AUC(0-last): Area Under the Plasma Concentration-time Curve From Time 0 to Last Extrapolated Concentration Over the Dosing Interval for Sapanisertib
Ramy czasowe: Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to last timepoint
|
AUC(0-last) is the area under the plasma concentration-time curve of the samples collected up to 8 hours and extrapolated up to last time point.
|
Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to last timepoint
|
Faza 1: Końcowy okres półtrwania w fazie eliminacji (T1/2) dla sapanisertib
Ramy czasowe: Cykl 1 Dzień 15 przed podaniem dawki i wiele punktów czasowych (do 8 godzin) po podaniu
|
Cykl 1 Dzień 15 przed podaniem dawki i wiele punktów czasowych (do 8 godzin) po podaniu
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (RZECZYWISTY)
Zakończenie podstawowe (RZECZYWISTY)
Ukończenie studiów (RZECZYWISTY)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (OSZACOWAĆ)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (RZECZYWISTY)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby skórne
- Nowotwory
- Nowotwory według lokalizacji
- Choroby piersi
- Nowotwory piersi
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Hormony, substytuty hormonów i antagoniści hormonów
- Środki przeciwnowotworowe, hormonalne
- Antagoniści hormonów
- Inhibitory aromatazy
- Inhibitory syntezy sterydów
- Antagoniści estrogenu
- Antagoniści receptora estrogenowego
- Fulwestrant
- Eksemestan
Inne numery identyfikacyjne badania
- C31001
- 2014-001921-34 (EUDRACT_NUMBER)
- U1111-1195-3894 (REJESTR: WHO)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Rak piersi
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Aktywny, nie rekrutującyGruczolakorak gruczołu krokowego III stopnia AJCC v7 | Gruczolakorak gruczołu krokowego II stopnia AJCC v7 | Stopień I gruczolakoraka gruczołu krokowego American Joint Committee on Cancer (AJCC) v7Stany Zjednoczone
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Emory UniversityNational Cancer Institute (NCI)WycofanePrognostyczny rak piersi IV stopnia AJCC v8 | Przerzutowy nowotwór złośliwy w mózgu | Przerzutowy rak piersi | Anatomiczny IV stopień raka piersi American Joint Committee on Cancer (AJCC) v8
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Jonsson Comprehensive Cancer CenterZakończonyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterZakończonyBiochemicznie nawracający rak prostaty | Przerzutowy rak prostaty | Nowotwór złośliwy z przerzutami w kości | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.RekrutacyjnyNiedrobnokomórkowy rak płuc z przerzutami | Oporny na leczenie niedrobnokomórkowy rak płuc | Rak płuca w stadium IV American Joint Committee on Cancer (AJCC) v8 | Rak płuc w stadium IVA AJCC v8 | Rak płuc w stadium IVB AJCC v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterRekrutacyjnyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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NRG OncologyNational Cancer Institute (NCI)Aktywny, nie rekrutującyAnatomiczny rak piersi IV stadium AJCC v8 | Prognostyczny rak piersi IV stopnia AJCC v8 | Nowotwór złośliwy z przerzutami w kości | Przerzutowy nowotwór złośliwy w węzłach chłonnych | Przerzutowy nowotwór złośliwy w wątrobie | Przerzutowy rak piersi | Przerzutowy nowotwór złośliwy w płucach | Nowotwór... i inne warunkiStany Zjednoczone, Kanada, Arabia Saudyjska, Republika Korei
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National Cancer Institute (NCI)ZakończonyOporny na leczenie złośliwy nowotwór lity | Nawracający złośliwy nowotwór lity | Przerzutowy złośliwy nowotwór lity | Nieoperacyjny lity nowotwór | Nawracający rak drobnokomórkowy płuca | Stopień IIIA Rak drobnokomórkowy płuca AJCC v7 | Etap IIIB Rak drobnokomórkowy płuca AJCC v7 | Rak drobnokomórkowy... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWycofanePrzerzutowy rak nerkowokomórkowy | Rak nerkowokomórkowy IV stopnia AJCC v8 | Rak brodawkowaty nerki | Zbieranie raka przewodów | Nieoperacyjny rak nerki | Dziedziczna leiomyomatoza i rak nerkowokomórkowy | Jasnokomórkowy brodawkowaty nowotwór nerki | Dziedziczny rak brodawkowaty nerki | Niesklasyfikowany... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterAstraZenecaZakończonyRak płaskonabłonkowy jamy ustnej i gardła | Stopień kliniczny III zależny od HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Stopień kliniczny II, w którym pośredniczy HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Patologiczny etap I, w którym pośredniczy HPV (p16-dodatni) rak jamy... i inne warunkiStany Zjednoczone