- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00606021
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Riyadh, Arabia Saudyjska, 11211
- 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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Assiut, Egipt, 0000
- 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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Cairo, Egipt, 11372
- 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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Mounofia, Egipt, 32514
- 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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Beirut, Liban
- 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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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion criteria:
- You must be at least 18 years old
- You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
- You must have had no prior systemic anticancer therapy for lung cancer
- You must live close enough to the study doctor to be able to visit regularly for follow up
- You must have signed informed consent form indicating your willingness to take part in this study
- Your laboratory and medical history and tests must meet study requirements
Exclusion criteria:
- Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
- Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
- Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
- Brain metastasis
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
- Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
- Concurrent administration of any other antitumor therapy
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
- Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
- Pregnancy or breast-feeding
- You are allergic to pemetrexed
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: A: Pemetrexed + Best Supportive Care
Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Inne nazwy:
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
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Aktywny komparator: B: Best Supportive Care
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
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Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Progression Free Survival During Maintenance Phase
Ramy czasowe: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
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Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause.
PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
PD is ≥20% increase in sum of longest diameter of target lesions.
PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
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Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Ramy czasowe: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
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Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause.
PD was determined using RECIST criteria.
PD is ≥20% increase in sum of longest diameter of target lesions.
PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
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First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
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Overall Survival During Maintenance Phase
Ramy czasowe: Randomization to PD or date of death from any cause up to 31.3 months
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Overall survival in maintenance phase is defined as the time from randomization to death.
Participants who were alive were censored at the last contact.
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Randomization to PD or date of death from any cause up to 31.3 months
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Overall Survival During Overall Period (IP + MP)
Ramy czasowe: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
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Overall survival in overall period is defined as the time from first dose of study drug during IP to death.
Participants who were alive were censored at the last contact.
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First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
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Number of Participants With Adverse Events (AEs) During Overall Period
Ramy czasowe: First dose of study drug during IP through overall study completion (up to 34.3) months
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The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
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First dose of study drug during IP through overall study completion (up to 34.3) months
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Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Ramy czasowe: Randomization to measured PD up to 31.4 months
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Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100.
Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR.
CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions.
SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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Randomization to measured PD up to 31.4 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
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 (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Oddechowego
- Nowotwory
- Choroby płuc
- Nowotwory według lokalizacji
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Rak, Bronchogenny
- Nowotwory oskrzeli
- Nowotwory płuc
- Rak, płuco niedrobnokomórkowe
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Antagoniści kwasu foliowego
- Pemetreksed
Inne numery identyfikacyjne badania
- 11839 (DAIDS ES)
- H3E-EZ-S114 (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Eureka Therapeutics Inc.Duke University; Duke Clinical Research InstituteZakończonyChłoniaki Non-Hodgkin's B-CellStany Zjednoczone
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Affiliated Hospital of Nantong UniversityJeszcze nie rekrutacja
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Austin HealthMerck KGaA, Darmstadt, GermanyAktywny, nie rekrutującyChłoniaki Non-Hodgkin's B-CellAustralia
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Institute of Hematology & Blood Diseases HospitalJuventas Cell Therapy Ltd.ZakończonyRecydywa | Chłoniaki Non-Hodgkin's B-CellChiny
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Gilead SciencesZakończonyChłoniak grudkowy | Chłoniak z komórek płaszcza | Przewlekła białaczka limfocytowa | Rozlany chłoniak z dużych komórek B | Non-FL Indolent Non-Hodgkin's LymphomaStany Zjednoczone, Kanada
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Malaghan Institute of Medical ResearchWellington Zhaotai Therapies LimitedAktywny, nie rekrutującyChłoniak z komórek płaszcza (MCL) | Rozlany chłoniak z dużych komórek B (DLBCL) | Chłoniak grudkowy (FL) | Chłoniaki Non-Hodgkin's B-Cell | Transformowany chłoniak grudkowy (TFL) | Pierwotny chłoniak śródpiersia z komórek B (PMBCL)Nowa Zelandia
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Estrella Biopharma, Inc.Eureka Therapeutics Inc.Jeszcze nie rekrutacjaChłoniak | Chłoniak nieziarniczy | Chłoniak nieziarniczy | Chłoniak nieziarniczy | Oporny na leczenie chłoniak nieziarniczy z komórek B | Oporny na leczenie chłoniak nieziarniczy | Chłoniak z komórek B wysokiego stopnia | Chłoniak OUN | Chłoniaki Non-Hodgkin's B-Cell | Nawracający chłoniak nieziarniczy | Chłoniak... i inne warunki
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Medical College of WisconsinRekrutacyjnyChłoniak grudkowy | Szpiczak mnogi | Chłoniak Burkitta | Chłoniak z komórek płaszcza | Przewlekła białaczka limfocytowa | Chłoniak, mały limfocytarny | Rozlany chłoniak z dużych komórek B | Chłoniak ośrodkowego układu nerwowego | Chłoniaki Non-Hodgkin's B-CellStany Zjednoczone
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Adelphi Values LLCBlueprint Medicines CorporationZakończonyBiałaczka z komórek tucznych (MCL) | Agresywna mastocytoza układowa (ASM) | SM w Assoc Clonal Hema Lineage Non-mast Cell Lineage Disease (SM-AHNMD) | Tląca się mastocytoza układowa (SSM) | Indolentna układowa mastocytoza (ISM) Podgrupa ISM w pełni zatrudnionaStany Zjednoczone
Badania kliniczne na pemetrexed
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Canadian Cancer Trials GroupOncolytics BiotechZakończonyNiedrobnokomórkowego raka płucaKanada