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- Klinische proef NCT00530621
Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
9 juni 2020 bijgewerkt door: Eli Lilly and Company
A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
160
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Gauting, Duitsland, 82131
- 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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Großhansdorf, Duitsland, D-22927
- 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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Köln, Duitsland, D-51109
- 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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Grenoble, Frankrijk, 38043
- 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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Marseille, Frankrijk, 13009
- 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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Saint Herblain, Frankrijk, 44805
- 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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Toulouse, Frankrijk, 31059
- 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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Villejuif, Frankrijk, 94805
- 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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Aviano, Italië, 33081
- 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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Genova, Italië, 16132
- 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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Orbassano, Italië, 10043
- 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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Seoul, Korea, republiek van, 135-710
- 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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Coimbra, Portugal, 3040-853
- 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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Lisbon, Portugal, 1099-035
- 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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Porto, Portugal, 4200-072
- 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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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
- 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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California
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Lancaster, California, Verenigde Staten, 93534
- 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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Los Angeles, California, Verenigde Staten, 90095
- 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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Florida
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Tampa, Florida, Verenigde Staten, 33612
- 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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Kansas
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Wichita, Kansas, Verenigde Staten, 67214
- 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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Maine
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Scarborough, Maine, Verenigde Staten, 04074
- 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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Ohio
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Dayton, Ohio, Verenigde Staten, 45429
- 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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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38120
- 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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Texas
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Fort Worth, Texas, Verenigde Staten, 76104
- 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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Richardson, Texas, Verenigde Staten, 75080
- 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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
- Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
- At least 1 measurable lesion.
- Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
- Must be able to follow study guidelines and be able to show up for appointments.
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.
- Previous treatment with enzastaurin or pemetrexed.
- Concurrent administration of any other antitumor therapy.
- Inability to swallow tablets.
- Pregnant or breastfeeding.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Pemetrexed + Enzastaurin
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1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
Andere namen:
500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Andere namen:
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Placebo-vergelijker: Pemetrexed + Placebo
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oraal, dagelijks
500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-Free Survival (PFS)
Tijdsspanne: Baseline to measured progressive disease up to 9.92 months
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PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria.
Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions.
PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.
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Baseline to measured progressive disease up to 9.92 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Survival (OS)
Tijdsspanne: Baseline to date of death from any cause up to 12.32 months
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OS was defined as the duration from the date of randomization to the date of death from any cause.
For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date the participant was last known to be alive.
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Baseline to date of death from any cause up to 12.32 months
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Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale
Tijdsspanne: Baseline to disease worsening up to 10.58 months
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LCSS is a participant rated lung cancer instrument which consisted of 6 disease related symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 quality of life (QoL) items (activity status, symptomatic distress, and overall QoL).
TW in LCSS-HRQoL was measured from the date of enrollment to the first date of a 15 millimeters (mm) worsening in the 9th LCSS item on QoL.
LCSS-HRQoL was measured on the 100-mm visual analogue scale (VAS) with the scores ranging from 0 (best response and very high HRQoL) to 100-mm (worse response and very low HRQoL).
TW-HRQoL was censored at the date of the participant's last LCSS assessment for participant without a 15-mm increase on the 100-mm VAS.
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Baseline to disease worsening up to 10.58 months
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Duration of Disease Control (DDC)
Tijdsspanne: Baseline to measured progressive disease up to 9.92 months
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DDC was defined as the time from randomization to the first documented observation of disease progression or death from any cause and was limited to the participants with a best tumor response of complete response (CR), partial response (PR), or stable disease (SD).
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria.
Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions.
CR was defined as the disappearance of all target lesions.
PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
SD was defined as small changes that did not meet the above criteria.
DDC was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.
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Baseline to measured progressive disease up to 9.92 months
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Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate)
Tijdsspanne: Baseline to measured progressive disease up to 9.92 months
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Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria.
Participants with a best response of complete response (CR) or partial response (PR) were considered to have had a tumor response.
CR was defined as the disappearance of all target lesions.
PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.
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Baseline to measured progressive disease up to 9.92 months
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Tumor Biomarkers
Tijdsspanne: Tumor samples collected at baseline
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Protein expression was measured using an Immunohistochemistry (IHC) assay from the tumor tissue samples.
IHC histo-scores (H-scores) were determined separately for each of the 3 biomarkers: folate receptor alpha (FR alpha) in cytoplasm and apical membrane, thymidylate synthase (TS) in cytoplasm and nucleus, and thyroid transcription factor-1 (TTF1) in the nucleus.
Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining.
IHC H-score was calculated using the formula: 1 * (percentage of cells stained 1+) + 2 * (percentage of cells stained 2+) + 3 * (percentage of cells stained 3+), giving a minimum score of 0 to a maximum score of 300.
The maximum score indicates the strongest expression.
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Tumor samples collected at baseline
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Who Died During the Study Treatment
Tijdsspanne: Baseline through study completion [up to 16 Cycles (21-day cycles, except Cycle 1 [28 days])]
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Reported are the deaths due to study disease and adverse events (AEs) that occurred while on study treatment.
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Baseline through study completion [up to 16 Cycles (21-day cycles, except Cycle 1 [28 days])]
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Number of Participants Who Died During the 30 Days After Treatment Discontinuation
Tijdsspanne: End of study treatment [16 Cycles (21-day cycles, except Cycle 1 [28 days])] through 30 days after treatment discontinuation
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Reported are the deaths due to study disease and adverse events (AEs) that occurred during the 30 days after treatment discontinuation.
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End of study treatment [16 Cycles (21-day cycles, except Cycle 1 [28 days])] through 30 days after treatment discontinuation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2007
Primaire voltooiing (Werkelijk)
1 oktober 2008
Studie voltooiing (Werkelijk)
1 oktober 2008
Studieregistratiedata
Eerst ingediend
13 september 2007
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2007
Eerst geplaatst (Schatting)
17 september 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juli 2020
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2020
Laatst geverifieerd
1 juni 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Antineoplastische middelen
- Foliumzuurantagonisten
- Pemetrexed
Andere studie-ID-nummers
- 9820
- H6Q-MC-JCBT (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Niet-kleincellige longkanker
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National Cancer Centre, SingaporeBeëindigdExtranodaal NK-T-CELL LYMFOMASingapore
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Adelphi Values LLCBlueprint Medicines CorporationVoltooidMastcelleukemie (MCL) | Agressieve systemische mastocytose (ASM) | SM w Assoc Clonal Hema Non-Mast Cell Lineage Disease (SM-AHNMD) | Smeulende systemische mastocytose (SSM) | Indolente systemische mastocytose (ISM) ISM-subgroep volledig gerekruteerdVerenigde Staten
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University of Alabama at BirminghamBeëindigdAnaplastisch grootcellig lymfoom | Angioimmunoblastisch T-cellymfoom | Perifere T-cellymfomen | Volwassen T-celleukemie | Volwassen T-cellymfoom | Perifeer T-cellymfoom niet gespecificeerd | T/Null Cell Systemisch Type | Cutaan t-cellymfoom met nodale / viscerale ziekteVerenigde Staten
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Masonic Cancer Center, University of MinnesotaWervingLymfoom | Folliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Myelofibrose | Juveniele myelomonocytaire leukemie | Burkitt lymfoom | Acute lymfatische leukemie | Lymfoblastisch lymfoom | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute leukemie | Mantelcellymfoom | Chronische myelogene... en andere voorwaardenVerenigde Staten
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Roswell Park Cancer InstituteActief, niet wervendAcute myeloïde leukemie | Polycytemie Vera | Myelofibrose | Chronische myelomonocytische leukemie | Waldenström Macroglobulinemie | Acute lymfatische leukemie | Chronische lymfatische leukemie | Secundaire acute myeloïde leukemie | Sikkelcelziekte | Myelodysplastisch syndroom | Plasmacelmyeloom | Chronische... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaActief, niet wervendFolliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Hodgkin lymfoom | Lymfoplasmacytisch lymfoom | Acute leukemie | Myelodysplastisch syndroom | Chronische myelogene leukemie | Prolymfatische Leukemie | Plasmacelleukemie | Beenmergfalensyndromen | Burkitt-lymfoom | Acute lymfoblastische leukemie... en andere voorwaardenVerenigde Staten
Klinische onderzoeken op placebo
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SamA Pharmaceutical Co., LtdOnbekendAcute bronchitis | Acute bovenste luchtweginfectieKorea, republiek van
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National Institute on Drug Abuse (NIDA)VoltooidCannabisgebruikVerenigde Staten
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyVoltooidMannelijke proefpersonen met diabetes type II (T2DM)Duitsland
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Heptares Therapeutics LimitedVoltooidFarmacokinetiek | Veiligheid problemenVerenigd Koninkrijk
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Soroka University Medical CenterVoltooid
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Regado Biosciences, Inc.VoltooidGezonde vrijwilligerVerenigde Staten
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Texas A&M UniversityNutraboltVoltooidGlucose and Insulin Response
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Longeveron Inc.BeëindigdHypoplastisch linkerhartsyndroomVerenigde Staten
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ItalfarmacoVoltooidBecker spierdystrofieNederland, Italië