- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02454478
Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)
7. März 2019 aktualisiert von: Eisai Co., Ltd.
Phase 1 Study of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic RCC
Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
7
Phase
- Phase 1
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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Chiba, Japan
- Eisai Trial Site #1
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Tokyo, Japan
- Eisai Trial Site #2
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Tokyo, Japan
- Eisai Trial Site #1
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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
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Voluntary agreement to provide written informed consent of this study.
- Willing and able to comply with all aspects of the protocol after being fully informed of the content.
- Males or females aged greater than or equal to 20 years at the time of informed consent.
- Histological or cytological confirmation of RCC.
- Participants must have confirmed diagnosis of unresectable advanced and/or metastatic RCC.
- Disease progression following vascular endothelial growth factor (VEGF) targeted therapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1.
- Adequately controlled blood pressure with or without the use of antihypertensive agents.
- Participants with adequate function of major organs.
- Adequate blood coagulation function, defined as international normalized ratio (INR) less than or equal to 1.5.
- Survival expectation of 3 months or longer after study enrollment.
- Participants with adequate washout period from the end of prior treatment to the start of study drug administration.
- Females of childbearing potential must not have had unprotected sexual intercourse within 28 days before participant registration and must agree to use a highly effective method of contraception throughout the entire study period and for 30 days after final administration of investigational drug. If currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during this study period or for 30 days after investigational drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before administration and must continue to use the same contraceptive during this study and for 30 days after investigational drug discontinuation.
- Male participants and their female partners must meet the criteria above.
Exclusion Criteria:
- Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
- Prior exposure to lenvatinib.
- Participants who have not recovered from toxicities to less than or equal to Grade 1 as a result of prior anticancer therapy, except alopecia.
- Major surgery within 3 weeks prior to the first dose of lenvatinib.
- Participants with a urine protein greater than or equal to 1 gram per 24 hours (g/24 hours).
- Uncontrollable diabetes as defined by fasting glucose greater than 1.5* upper limit of normal (ULN).
- Fasting total cholesterol greater than 7.75 millimole per liter (mmol/L) (greater than 300 milligram per decilitre [mg/dL]).
- Fasting triglycerides greater than 2.5 * ULN.
- Any condition that might affect the absorption of lenvatinib and/or everolimus.
- Significant cardiovascular impairment.
- Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring.
- Active hemoptysis.
- Active infections that require systemic treatment.
- Human immunodeficiency virus (HIV) positive.
- Hepatitis B virus (HBV).
- A history of interstitial pneumonia with clinical manifestation or as confirmed by means of diagnostic imaging.
- Medical need for the continued use of potent or moderate inhibitors of cytochrome P450 3A (CYP3A) or P-gp, or potent or moderate inducer of CYP3A.
- Known intolerance to lenvatinib (or any of the excipients) or known hypersensitivity to everolimus (or any of the excipients) or rapmycins (sirolimus, temsirolimus and so on).
- Alcohol or drug dependency or abuse, inability to comply with every aspects of the study protocol, or any physical or mental conditions that in the opinion of the investigators would preclude the participant's participation in the study.
- Females who are pregnant or breastfeeding (not eligible even she discontinues breastfeeding).
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Lenvatinib plus Everolimus
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Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
Zeitfenster: From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)
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DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
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From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Zeitfenster: Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
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Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus
Zeitfenster: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus
Zeitfenster: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus
Zeitfenster: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus
Zeitfenster: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Zeitfenster: Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Number of Participants With Best Overall Response (BOR)
Zeitfenster: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease).
BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
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From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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Objective Response Rate (ORR)
Zeitfenster: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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ORR was defined as the percentage of participants who achieved BOR of CR or PR.
ORR was assessed using RECIST 1.1.
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From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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Disease Control Rate (DCR)
Zeitfenster: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD.
DCR was assessed based on RECIST 1.1.
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From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
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Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions
Zeitfenster: Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)
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Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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 (Tatsächlich)
1. Juli 2015
Primärer Abschluss (Tatsächlich)
29. Mai 2017
Studienabschluss (Tatsächlich)
29. Mai 2017
Studienanmeldedaten
Zuerst eingereicht
22. Mai 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Mai 2015
Zuerst gepostet (Schätzen)
27. Mai 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. März 2019
Zuletzt verifiziert
1. September 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Urologische Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Nierenerkrankungen
- Urologische Erkrankungen
- Adenokarzinom
- Neubildungen, Drüsen und Epithelien
- Nierentumoren
- Karzinom, Nierenzelle
- Karzinom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Proteinkinase-Inhibitoren
- Everolimus
- Lenvatinib
Andere Studien-ID-Nummern
- E7080-J081-112
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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