A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
9. august 2016 oppdatert av: Genentech, Inc.
A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma
This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer.
The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
56
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85013
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California
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Newport Beach, California, Forente stater, 92663
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Orange, California, Forente stater, 92868
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Palo Alto, California, Forente stater, 94305
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San Francisco, California, Forente stater, 94115
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Colorado
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Denver, Colorado, Forente stater, 80220
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
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Florida
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Boca Raton, Florida, Forente stater, 33487
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Orlando, Florida, Forente stater, 32804
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West Palm Beach, Florida, Forente stater, 33401
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Illinois
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Hinsdale, Illinois, Forente stater, 60521
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Indiana
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Indianapolis, Indiana, Forente stater, 46237
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
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Maine
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Scarborough, Maine, Forente stater, 04074
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Maryland
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Baltimore, Maryland, Forente stater, 21231
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
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Boston, Massachusetts, Forente stater, 02115-6084
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New Jersey
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Voorhees, New Jersey, Forente stater, 08043
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New York
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New York, New York, Forente stater, 10016
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New York, New York, Forente stater, 10017
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North Carolina
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Durham, North Carolina, Forente stater, 27710
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Winston-salem, North Carolina, Forente stater, 27103
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19001
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Pittsburgh, Pennsylvania, Forente stater, 15213
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Utah
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Salt Lake City, Utah, Forente stater, 84112
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Washington
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Seattle, Washington, Forente stater, 98195
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
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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
Hunn
Beskrivelse
Inclusion Criteria:
- Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments
- Histologic confirmation of the original primary tumor is required
- Histologic or cytologic confirmation of the recurrent/progressive disease is desired
- Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma
- Disease that is measurable per RECIST v1.1
- No active infection requiring antibiotics
- Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment
- Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
- Adequate hematologic and end organ function
Exclusion Criteria:
- Type I diabetes or Type II diabetes requiring insulin
- Prior use of mTOR/PI3K inhibitor
- Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
- Previous diagnosis of pulmonary fibrosis of any cause
- History of myocardial infarction or unstable angina within 6 months prior to first study treatment
- Congestive heart failure
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
- Presence of positive test results for hepatitis B or hepatitis C
- Known HIV infection
- Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
- Need for current chronic corticosteroid therapy
- Pregnancy, lactation, or breastfeeding
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
- Uncontrolled hypercalcemia
- Leptomeningeal disease as a manifestation of cancer
- Known untreated or active brain metastases
- Grade >=2 hypercholesterolemia or hypertriglyceridemia
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: EN
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Oral daily dose
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Objective tumor response as assessed by the investigator using RECIST v1.1
Tidsramme: up to approximately 23 months
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up to approximately 23 months
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Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study
Tidsramme: at 6 months
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at 6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Overall survival (OS), defined as the time from treatment initiation until death from any cause
Tidsramme: up to approximately 36 months
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up to approximately 36 months
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Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1
Tidsramme: up to approximately 23 months
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up to approximately 23 months
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Incidence of adverse events
Tidsramme: up to approximately 23 months
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up to approximately 23 months
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Nature of adverse events
Tidsramme: up to approximately 23 months
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up to approximately 23 months
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Severity of adverse events
Tidsramme: up to approximately 23 months
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up to approximately 23 months
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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
1. desember 2011
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først innsendt
18. oktober 2011
Først innsendt som oppfylte QC-kriteriene
18. oktober 2011
Først lagt ut (Anslag)
20. oktober 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PIM4972g
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. .