A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
9. august 2016 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
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California
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Newport Beach, California, Forenede Stater, 92663
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Orange, California, Forenede Stater, 92868
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Palo Alto, California, Forenede Stater, 94305
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San Francisco, California, Forenede Stater, 94115
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Colorado
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Denver, Colorado, Forenede Stater, 80220
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
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Florida
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Boca Raton, Florida, Forenede Stater, 33487
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Orlando, Florida, Forenede Stater, 32804
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West Palm Beach, Florida, Forenede Stater, 33401
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Illinois
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Hinsdale, Illinois, Forenede Stater, 60521
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46237
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
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Maine
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Scarborough, Maine, Forenede Stater, 04074
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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Boston, Massachusetts, Forenede Stater, 02115-6084
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New Jersey
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Voorhees, New Jersey, Forenede Stater, 08043
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New York
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New York, New York, Forenede Stater, 10016
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New York, New York, Forenede Stater, 10017
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
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Winston-salem, North Carolina, Forenede Stater, 27103
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
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Washington
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Seattle, Washington, Forenede Stater, 98195
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: EN
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Oral daily dose
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Hvad måler undersøgelsen?
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
18. oktober 2011
Først indsendt, der opfyldte QC-kriterier
18. oktober 2011
Først opslået (Skøn)
20. oktober 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PIM4972g
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 .