- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00533429
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Arkansas
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Bentonville, Arkansas, Stany Zjednoczone, 72712
- 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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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- 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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Galesburg, Illinois, Stany Zjednoczone, 61401
- 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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Indiana
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Bloomington, Indiana, Stany Zjednoczone, 47403
- 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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Evansville, Indiana, Stany Zjednoczone, 47714
- 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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Fort Wayne, Indiana, Stany Zjednoczone, 46815
- 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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Indianapolis, Indiana, Stany Zjednoczone, 46202
- 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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Lafayette, Indiana, Stany Zjednoczone, 47904
- 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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Muncie, Indiana, Stany Zjednoczone, 47303
- 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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South Bend, Indiana, Stany Zjednoczone, 46601
- 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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Michigan
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Jackson, Michigan, Stany Zjednoczone, 49201
- 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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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68114
- 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:
- participants or their legal representative must have signed an informed consent document for clinical research
- have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung cancer (NSCLC) (Stage IIIB or IV disease) which is not curable
- have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
- have measurable disease
- have adequate organ function and estimated life expectancy of 12 weeks
Exclusion Criteria:
- have known central nervous system (CNS) disease; major surgery within 28 days; minor surgery within 7 days; serious concomitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
- have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
- have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
- are pregnant or breast-feeding
- are unable to swallow tablets
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
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1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression
Inne nazwy:
500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
Inne nazwy:
Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
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Komparator placebo: B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
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500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
Inne nazwy:
Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
oral, daily
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Progression-Free Survival (PFS)
Ramy czasowe: Randomization to measured PD or death from any cause up to 12.2 months
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PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause.
For participants not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of the last objective progression-free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.
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Randomization to measured PD or death from any cause up to 12.2 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)
Ramy czasowe: Randomization to measured progressive disease or death from any cause up to 12.2 months
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Tumor response rate was defined as number of participants with overall best response of CR or PR over number of protocol qualified participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case, no new lesions may have appeared. Percentage of participants was calculated as: (number of participants with CR or PR/ number of participants qualified for tumor response analysis) × 100. |
Randomization to measured progressive disease or death from any cause up to 12.2 months
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Overall Survival (OS)
Ramy czasowe: Randomization to date of death up to 14.3 months
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OS was defined as the time from the date of randomization to the date of death from any cause.
For participants who were not known to have died as of the data cutoff, OS was censored at the last contact date.
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Randomization to date of death up to 14.3 months
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Time to Progressive Disease (TTPD)
Ramy czasowe: Randomization to measured PD or death from any cause up to 12.2 months
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TTPD was defined as the time from the date of randomization until the first date of objectively determined progressive disease (PD).
For participants who died without objective PD (including death from study disease), TTPD was censored at the date of the last objective progression-free disease assessment.
For participants not known to have died as of the data cutoff and did not have PD, TTPD was censored at the date of the last objective progression-free disease assessment.
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Randomization to measured PD or death from any cause up to 12.2 months
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Duration of Response (DoR)
Ramy czasowe: Time of response to disease progression or death from any cause up to 12.2 months
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The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death from any cause.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria.
CR was defined as the disappearance of all target lesions and PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs.
For participants who died without progressive disease or who were alive, DoR was censored at the last contact of progression free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to PD, DoR was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.
Due to early study closure, DoR was not analyzed.
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Time of response to disease progression or death from any cause up to 12.2 months
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Pharmacology Toxicity and Adverse Events (AEs)
Ramy czasowe: Randomization up to 14.3 months and 30-day follow-up
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Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs.
Participants who died due to progressive disease (PD) or an AE while on treatment and or died during the 30 day post-treatment follow-up are included.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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Randomization up to 14.3 months and 30-day follow-up
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Współpracownicy i badacze
Sponsor
Współpracownicy
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 (Rzeczywisty)
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
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Środki przeciwnowotworowe, immunologiczne
- Inhibitory angiogenezy
- Środki modulujące angiogenezę
- Substancje wzrostowe
- Inhibitory wzrostu
- Antagoniści kwasu foliowego
- Karboplatyna
- Bewacyzumab
- Pemetreksed
Inne numery identyfikacyjne badania
- 11398
- H6Q-MC-S034 (Inny identyfikator: Eli Lilly and Company)
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