- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00854152
A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
1. november 2016 opdateret af: Genentech, Inc.
An Open-label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
121
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sutton, Det Forenede Kongerige, SM2 5PT
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
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New York
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New York, New York, Forenede Stater, 10065
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
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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
Alle
Beskrivelse
Inclusion Criteria:
- Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
- ECOG performance status of 0 or 1 at screening
- Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
- Life expectancy >=12 weeks
- Adequate hematologic and organ function within 14 days before initiation of GDC-0980
- Documented willingness to use an effective means of contraception for both men and women while participating in the study
Exclusion Criteria:
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Grade >= 2 hypercholesterolemia or hypertriglyceridemia
- Ejection fraction that is <50% or below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
- DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume prior to initiation of GDC-0980
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Active infection requiring IV antibiotics
- Requirement for any daily supplemental oxygen
- Uncontrolled hypomagnesemia
- Hypercalcemia requiring continued use of bisphosphonate therapy
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Uncontrolled ascites requiring frequent paracentesis
- Known HIV infection
- Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
- Significant traumatic injury within 4 weeks of Day 1
- Major surgical procedure within 4 weeks prior to initiation of GDC-0980
- For all patients participating in Stage 2: Prior treatment with any PI3K inhibitor, mTOR inhibitor or dual PI3K/mTOR inhibitor. For HNSCC patients, this restriction applies only to any PI3K inhibitor, mTOR inhibitor, or dual PI3K/mTOR inhibitor used in the palliative setting.
- Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980
- Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980
- Need for chronic corticosteroid therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
- Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980
- Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy
- Pregnancy or lactation
- For patients participating in DCE-MRI assessments, any contraindication to MRI examination
- For patients with advanced solid tumors or NHL participating in the PPI-effect assessment: Known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
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Escalating repeating dose
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Occurrence of adverse events
Tidsramme: Length of study
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Length of study
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Occurrence of dose-limiting toxicities
Tidsramme: Length of study
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Length of study
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Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980
Tidsramme: Length of study
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Length of study
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PK parameters after doses of GDC-0980
Tidsramme: Length of study
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Length of study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Best overall response, duration of objective response, and progression-free survival for patients with measurable disease
Tidsramme: Length of study
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Length of study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Mika Derynck, M.D., Genentech, Inc.
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. marts 2009
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
27. februar 2009
Først indsendt, der opfyldte QC-kriterier
27. februar 2009
Først opslået (Skøn)
3. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PIM4604g
- MP00880 (Anden identifikator: Hoffmann-La Roche)
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 Non-Hodgkins lymfom, faste kræftformer
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Jecho Biopharmaceuticals Co., Ltd.Ikke rekrutterer endnuSolid tumorkræft | Maligniteter | Solid ondartet tumor | NHL (Non-Hodgkin lymfom)
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Antengene Therapeutics LimitedAfsluttetSolid tumor, non-Hodgkins lymfomKina, Taiwan
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Changchun GeneScience Pharmaceutical Co., Ltd.AfsluttetSolid tumor | Non-Hodgkin lymfomKina
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Adagene (Suzhou) LimitedAfsluttetSolid tumor | Non-Hodgkin lymfomKina
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Tarapeutics Science Inc.RekrutteringAvanceret solid tumor | Non-Hodgkins lymfom, tilbagefald | Non-Hodgkins lymfom refraktærKina
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Jiangsu Simcere Pharmaceutical Co., Ltd.RekrutteringSolid tumor | Non Hodgkin lymfomKina
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Adagene (Suzhou) LimitedAfsluttetSolid tumor | Non Hodgkin lymfomKina
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University of California, San DiegoThe Institute for Follicular Lymphoma InnovationRekrutteringSolid tumor | Non Hodgkin lymfomForenede Stater
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Genentech, Inc.AfsluttetNon-Hodgkins lymfom | Solid kræftForenede Stater, Spanien, Frankrig, Canada
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Pacylex PharmaceuticalsOzmosis Research Inc.AfsluttetAvanceret solid tumor | B-celle non-hodgkin lymfomCanada
Kliniske forsøg med GDC-0980
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Genentech, Inc.Afsluttet
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Genentech, Inc.AfsluttetBrystkræftBelgien, Israel, Forenede Stater, Spanien, Danmark, Tyskland, Hong Kong, Den Russiske Føderation, Australien, New Zealand, Korea, Republikken, Malaysia, Singapore, Italien, Tjekkiet, Frankrig, Peru, Canada, Det Forenede Kongerige og mere
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Genentech, Inc.AfsluttetNyrecellekarcinomTyskland, Spanien, Forenede Stater, Frankrig, Det Forenede Kongerige
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Genentech, Inc.Afsluttet
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Genentech, Inc.AfsluttetSolid kræftSpanien, Forenede Stater
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Genentech, Inc.Afsluttet
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Genentech, Inc.AfsluttetSund frivilligForenede Stater
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Genentech, Inc.AfsluttetSunde frivilligeDet Forenede Kongerige
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Genentech, Inc.Afsluttet
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Genentech, Inc.AfsluttetLupus erythematosus, systemiskForenede Stater, Korea, Republikken, Spanien, Taiwan, Bulgarien, Colombia, Brasilien, Argentina, Mexico, Chile, Det Forenede Kongerige