- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00975806
Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Main Campus
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Metastatic Renal Cell Carcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Exclusion Criteria:
- Prior chemotherapy.
- Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.
- Laboratory values outside normal ranges.
- Myocardial infarction (MI) within past 12 months.
- Current congestive heart failure.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Cohort A
Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle
|
Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
Andre navne:
Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
Andre navne:
|
Eksperimentel: Cohorts F and G
Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle
|
Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
Andre navne:
Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Phase 1: Maximum Tolerated Dose (MTD)
Tidsramme: Within 21 days of first dose of treatment
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The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation. |
Within 21 days of first dose of treatment
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Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Tidsramme: After at least 3 cycles of treatment
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Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
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After at least 3 cycles of treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib
Tidsramme: First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
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Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology.
Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
TEAE = any AE occurring or worsening on or after the first treatment with any study drug.
Related = suspected by investigator to be related to study treatment.
National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death
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First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
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Phase 1 : Tumor Response Rate According to RECIST 1.1
Tidsramme: Every 3 cycles; up to month 25
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Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria: Treatment response includes both complete response and partial response
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Every 3 cycles; up to month 25
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Progression Free Survival (PFS)
Tidsramme: Day 1 of study drug to disease progression or death
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Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.
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Day 1 of study drug to disease progression or death
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Duration of Response
Tidsramme: Day 1 of initial response date to progressive disease
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Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)
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Day 1 of initial response date to progressive disease
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Overall Survival (OS)
Tidsramme: Day 1 of study drug to death
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Overall survival was defined as the time from the start of study drug therapy to death.
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Day 1 of study drug to death
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Debora Barton, MD, Celgene Corporation
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Karcinom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Sunitinib
- Lenalidomid
Andre undersøgelses-id-numre
- CC-5013-RCC-001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nyrecellekarcinom
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk Ureter Urothelial Carcinoma | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Metastatisk nyrebækken og Ureter Urothelial CarcinomaForenede Stater
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Association Pour La Recherche des Thérapeutiques...AfsluttetClear Cell Metastatic Renal Cell CarcinomaFrankrig
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Universitaire Ziekenhuizen KU LeuvenAfsluttetForekomst af Augmented Renal Clearance | Risikofaktorer for øget renal clearanceBelgien
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The First People's Hospital of ChangzhouIkke rekrutterer endnu
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Metastatisk Urothelial Carcinom | Lokalt avanceret blæreurothelial karcinom | Lokalt avanceret nyrebækken Urothelial Carcinoma | Lokalt... og andre forholdForenede Stater
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Medical University of ViennaAfsluttetGlomerulær filtreringshastighed | Fedtsyrer, ikke-esterificerede | Renal Cirkulation | Renal Plasma FlowØstrig
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Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.Trukket tilbageMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Uoperabelt nyrebækken Urothelial Carcinom | Uoperabelt Ureter Urothelial CarcinomaForenede Stater
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