A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)
2020. január 10. frissítette: Eli Lilly and Company
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
A tanulmány áttekintése
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
132
Fázis
- 2. fázis
Kiterjesztett hozzáférés
Elérhető a klinikai vizsgálaton kívül.
Lásd a bővített hozzáférési rekordot.
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Brussel, Belgium, 1000
- 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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Charleroi, Belgium, 6000
- 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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Leuven, Belgium, 3000
- 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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Liège, Belgium, 4000
- 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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Arizona
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Sedona, Arizona, Egyesült Államok, 86336
- Northern Arizona Hematology & Oncology Associates
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Tucson, Arizona, Egyesült Államok, 85715
- Arizona Clinical Research Center
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Tucson, Arizona, Egyesült Államok, 85704
- HOPE Hematology Oncology Physicians and Extenders
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California
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San Francisco, California, Egyesült Államok, 94115
- Univ of California San Francisco
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Santa Barbara, California, Egyesült Államok, 93105
- Sansum Medical Research Foundation
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Colorado
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Denver, Colorado, Egyesült Államok, 80220
- Rocky Mountain Cancer Center
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District of Columbia
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Washington, District of Columbia, Egyesült Államok, 20010
- Washington Hospital Center
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Florida
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Fort Myers, Florida, Egyesült Államok, 33916
- Florida Cancer Specialists
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Miami, Florida, Egyesült Államok, 33176
- Advanced Medical Specialties
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Saint Petersburg, Florida, Egyesült Államok, 33705
- Florida Cancer Specialists
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Maryland
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Columbia, Maryland, Egyesült Államok, 21044
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston, Massachusetts, Egyesült Államok, 02115
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Egyesült Államok, 55404
- Minnesota Oncology/Hematology PA
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New York
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New York, New York, Egyesült Államok, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cincinnati, Ohio, Egyesült Államok, 45242
- Oncology Hematology Care Inc
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Tennessee
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Nashville, Tennessee, Egyesült Államok, 37203
- Sarah Cannon Research Institute SCRI
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Texas
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Austin, Texas, Egyesült Államok, 78731
- Texas Oncology Cancer Center
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Bedford, Texas, Egyesült Államok, 76022
- Texas Oncology - Bedford
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Dallas, Texas, Egyesült Államok, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Egyesült Államok, 75231
- Presbyterian Hospital Dallas
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Fort Worth, Texas, Egyesült Államok, 76104
- The Center for Cancer and Blood Disorders
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Houston, Texas, Egyesült Államok, 77024
- Texas Oncology-Memorial City
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Plano, Texas, Egyesült Államok, 75093
- Texas Oncology-Plano West
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Sherman, Texas, Egyesült Államok, 75090-0504
- Texas Oncology-Sherman
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The Woodlands, Texas, Egyesült Államok, 77380
- US Oncology
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Tyler, Texas, Egyesült Államok, 75702
- Tyler Cancer Center
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Washington
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Vancouver, Washington, Egyesült Államok, 98684
- Northwest Cancer Specialists PC
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Dijon, Franciaország, 21034
- 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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Paris, Franciaország, 75248
- 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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Barcelona, Spanyolország, 08035
- 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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Madrid, Spanyolország, 28007
- 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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Valencia, Spanyolország, 46015
- 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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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Női
Leírás
Inclusion Criteria.
- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
Prior treatment with at least 2 chemotherapy regimens:
- At least 1 of these regimens must have been administered in the metastatic setting.
- At least 1 of these regimens must have contained a taxane.
- No more than 2 prior chemotherapy regimens in the metastatic setting.
- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
- Have discontinued all previous therapies for cancer.
- Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion Criteria:
- Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- Have had major surgery within 14 days of the initial dose of study drug.
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle).
Participants may continue to receive treatment until discontinuation criteria are met.
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Orálisan beadva
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Időkeret: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Overall Survival (OS)
Időkeret: From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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OS defined as the time from first dose date to the date of death due to any cause.
For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
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From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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Duration of Response (DOR)
Időkeret: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier.
CR and PR were defined using the RECIST v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
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From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Progression Free Survival (PFS)
Időkeret: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant.
If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
Időkeret: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
Időkeret: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months.
CR, PR, or SD were defined using RECIST, v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
Időkeret: Cycle 6 Day 1
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A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
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Cycle 6 Day 1
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Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
Időkeret: Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
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Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
Időkeret: Cycle 6 Day 1
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EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties.
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
For functional domains and global health status, higher scores represent a better level of functioning.
For symptoms scales, higher scores represented a greater degree of symptoms.
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Cycle 6 Day 1
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2014. június 10.
Elsődleges befejezés (Tényleges)
2016. április 30.
A tanulmány befejezése (Tényleges)
2018. október 22.
Tanulmányi regisztráció dátumai
Először benyújtva
2014. március 31.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2014. március 31.
Első közzététel (Becslés)
2014. április 3.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. január 21.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. január 10.
Utolsó ellenőrzés
2020. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 15419
- I3Y-MC-JPBN (Egyéb azonosító: Eli Lilly and Company)
- 2013-005548-27 (Egyéb azonosító: EudraCT Number)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
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.
IPD megosztási időkeret
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.
IPD-megosztási hozzáférési feltételek
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- CSR
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .