- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01875705
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
5. april 2018 oppdatert av: Genentech, Inc.
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors.
Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II).
Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily.
Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06520
- Yale Cancer Center; Medical Oncology
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48201
- Karmanos Can Inst
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37203
- Sarah Cannon Research Inst.
-
-
-
-
-
Villejuif, Frankrike, 94805
- Institut Gustave Roussy; Departement Oncologie Medicale
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
- Evaluable disease or disease measurable per RECIST 1.1
- Life expectancy >= 12 weeks
- Adequate hematologic and end organ function
- Consent to provide archival tissue
Exclusion Criteria:
- History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment
- History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
- Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment
- History of glaucoma
- Intraocular pressure > 21 mmHg as measured by tonometry
- Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
- History of retinal vein occlusion (RVO), neurosensory retinal detachment, or neovascular macular degeneration
- Allergy or hypersensitivity to components of the GDC-0994 formulation
- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
- Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
- Prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer
- Current severe, uncontrolled systemic disease
- History of clinically significant cardiac dysfunction
- Pregnancy, lactation, or breastfeeding
- Active autoimmune disease
- Inability or unwillingness to swallow pills
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
- Any condition requiring warfarin or thrombolytic anticoagulants
- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Stage I-Dose Escalation
|
Escalating doses of GDC-0994 until maximum tolerated dose is reached
Recommended dose determined in Stage I-Dose Escalation phase, until disease progression
|
Eksperimentell: Stage II-Cohort-Expansion
|
Escalating doses of GDC-0994 until maximum tolerated dose is reached
Recommended dose determined in Stage I-Dose Escalation phase, until disease progression
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Safety: Incidence of adverse events
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Maximum tolerated dose
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Dose-limiting toxicities
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Pharmacokinetics: Area under the concentration-time curve
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Pharmacokinetics: Maximum plasma concentrations
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Pharmacokinetics: Minimum plasma concentrations
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Pharmacokinetics: Time to maximum plasma concentration
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Pharmacokinetics: Apparent terminal elimination half-life
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess the PD effects of GDC-0994, as measured by changes in molecular biomarkers in pre- and post-treatment tumor tissues\n
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. juni 2013
Primær fullføring (Faktiske)
23. september 2016
Studiet fullført (Faktiske)
23. september 2016
Datoer for studieregistrering
Først innsendt
10. juni 2013
Først innsendt som oppfylte QC-kriteriene
11. juni 2013
Først lagt ut (Anslag)
12. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GO28885
- 2013-000566-10 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Solid svulst
-
Istituto Clinico HumanitasFullført
-
Incyte CorporationAvsluttetSolid tumor malignitetForente stater, Frankrike, Storbritannia, Italia, Korea, Republikken, Japan, Spania, Israel, Danmark, Tyskland, Sveits
-
Martin GutierrezHackensack Meridian Health; Karyopharm Therapeutics IncTilbaketrukket
-
Cytovation ASMerck Sharp & Dohme LLCAktiv, ikke rekrutterendeAvansert solid tumor malignitetNederland, Frankrike, Spania
-
Kling Biotherapeutics B.V.RekrutteringAvansert solid tumor malignitetBelgia, Nederland
-
NewLink Genetics CorporationAvsluttetAvansert solid tumor malignitetForente stater
-
Livzon Pharmaceutical Group Inc.Palm Beach CRO; Keystone Bioanalytical, Inc.FullførtSolid tumor motstandsdyktig mot standard terapiForente stater
-
Royal Marsden NHS Foundation TrustAstraZeneca; Cancer Research UK; RM/ICR Biomedical Research CentreAktiv, ikke rekrutterendeSolid tumor motstandsdyktig mot konvensjonell behandlingStorbritannia
-
AkesoAkeso Pharmaceuticals, Inc.AvsluttetMSI-H/dMMR Solid TumorKina
-
Second Affiliated Hospital, School of Medicine,...Rekruttering
Kliniske studier på GDC-0994
-
Genentech, Inc.FullførtIkke-småcellet lungekreft, metastatisk tykktarmskreft, metastatisk ikke-småcellet lungekreft, metastatisk kreft, melanomForente stater
-
Genentech, Inc.Fullført
-
Genentech, Inc.Fullført
-
Genentech, Inc.Fullført
-
Genentech, Inc.FullførtFriske FrivilligeStorbritannia
-
Genentech, Inc.AvsluttetLupus erythematosus, systemiskForente stater, Korea, Republikken, Spania, Taiwan, Bulgaria, Colombia, Brasil, Argentina, Mexico, Chile, Storbritannia
-
Genentech, Inc.Fullført
-
National Cancer Institute (NCI)Genentech, Inc.AvsluttetKronisk graft versus vertssykdomForente stater
-
Stanford UniversityNational Cancer Institute (NCI); University Hospitals Cleveland Medical...FullførtTilbakevendende hudkreft | Basalcellekarsinom i hudenForente stater