Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
9. Juni 2020 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
160
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Gauting, Deutschland, 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, Deutschland, 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, Deutschland, 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, Frankreich, 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, Frankreich, 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, Frankreich, 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, Frankreich, 31059
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Villejuif, Frankreich, 94805
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Aviano, Italien, 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, Italien, 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, Italien, 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, Republik von, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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, Vereinigte Staaten, 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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-Komparator: Pemetrexed + Placebo
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mündlich, täglich
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Progression-Free Survival (PFS)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Overall Survival (OS)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants Who Died During the Study Treatment
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2007
Primärer Abschluss (Tatsächlich)
1. Oktober 2008
Studienabschluss (Tatsächlich)
1. Oktober 2008
Studienanmeldedaten
Zuerst eingereicht
13. September 2007
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. September 2007
Zuerst gepostet (Schätzen)
17. September 2007
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Juli 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2020
Zuletzt verifiziert
1. Juni 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Molekulare Mechanismen der pharmakologischen Wirkung
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Folsäure-Antagonisten
- Pemetrexed
Andere Studien-ID-Nummern
- 9820
- H6Q-MC-JCBT (Andere Kennung: Eli Lilly and Company)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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