- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00309179
A Phase II Study of the Safety and Efficacy of E7820 Plus Cetuximab in Colorectal Cancer, Preceded by a Run-in Study in Advanced Solid Tumors
6. september 2017 opdateret af: Eisai Inc.
A Single Arm Phase II Study of the Efficacy, Safety, and Biomarkers of Activity of E7820 Plus Cetuximab in Advanced Solid Tumors Preceded by a Run-In Study to Determine Safety of the Combination
This study proposes to determine the safety of the administration of E7820 plus cetuximab and explore the MTD of the combination in a Phase Ib study.
In addition, the efficacy of this combination will be explored in patients with colorectal cancer in the Phase II proof of concept phase of the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
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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Alberta
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Edmonton, Alberta, Canada
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California
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Los Angeles, California, Forenede Stater
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Florida
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Miami, Florida, Forenede Stater
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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:
- For Phase Ib, patients must have a histologically or cytologically confirmed malignant solid tumor for which no effective therapy is available or the patient must not be a candidate for standard therapy.
- For Phase II, patients must have a pathologically and histologically documented colorectal carcinoma that is inoperable and/or metastatic. These patients must also have at least one unidimensional measurable lesion according to the RECIST guidelines.
- Patients must have an ECOG Performance Status of 0-1.
- Patients must have a life expectancy of >= 3 months.
- Patients must be aged >= 18 years.
- Patients must have adequate renal function as evidenced by serum creatinine < 2 mg/dL and creatinine clearance > 40 mL/minute.
- Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 /mm3 and platelets >= 100,000 /mm3.
- Patients must have adequate hepatic function as evidenced by liver function test abnormalities no greater than CTC grade 1 (bilirubin, alanine transaminase [ALT], and aspartate transaminase [AST]) unless increased LFTs are related to liver metastases in which case CTC grade 2 abnormalities acceptable.
- Patients must be willing and able to comply with the study protocol for the duration of the study.
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
- Patients may have received prior bevacizumab therapy as long as therapy has been discontinued for 4 weeks or longer.
Exclusion Criteria:
- Patients who have a history of previous Grade 2 or higher hypersensitivity to sulfonamide derivatives.
- Patients previously treated with cetuximab, or who have received prior treatment with any EGFR-related cancer therapy, either an approved or investigational agent.
- Patients with known sensitivity to murine monoclonal antibodies.
- Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks prior to E7820 treatment.
- Patients who have not recovered from any clinically significant (Grade 3 or 4) chemotherapy, immunotherapy, or radiotherapy related toxicity at study entry (excluding neuropathy, infertility, or alopecia).
- Patients who have received investigational drugs or any other anti-neoplastic therapy within 28 days of E7820 treatment.
- Patients who have had major surgery within 4 weeks of study drug administration.
- Women who are pregnant or breast-feeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception.
- Patients with brain or subdural metastases are not eligible except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least one month before starting treatment with E7820. Any signs (eg, radiologic) and/or symptoms from their brain metastases must be stable for at least one month.
- Patients who have a positive history of human immunodeficiency virus, hepatitis B or active hepatitis C.
- Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies).
- Patients with a history of unstable ischemic cardiac disease or more than Class II NYHA heart failure.
- Patients with a history of clinically significant arterial thrombosis or who have taken therapeutic doses of anticoagulants within the last 7 days.
- Patients who have pulmonary disease that puts them at risk of hemoptysis or bleeding diathesis. Head and neck cancer patients at risk for major vessel bleeding.
- Patients receiving therapeutics doses of anticoagulants.
- Patients with poorly controlled type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose >10 mmol/L (200 mg/dL).
- Patients with significant comorbid disease or condition, which in the Investigator's opinion would exclude the patient from the study.
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: 1
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Escalating doses from 40 mg/m^2 irinotecan plus E7820 in combination with cetuximab.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Objective tumor response (CR or PR) and disease control (CR, PR or SD) rates will be evaluated in this study based on RECIST criteria and modified WHO criteria.
Tidsramme: The timing will be based on RECIST criteria and modified WHO criteria.
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The timing will be based on RECIST criteria and modified WHO criteria.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pharmacokinetics: Blood samples will be taken on Days 1, 2, and 15 during Cycle 1 and Day 1. Pharmacodynamics: Blood will be taken prior to dosing on Day 1, Days 1, 2, and 15 during Cycle 1 and Day 1.
Tidsramme: Days 1, 2, and 15 during Cycle 1 and Day 1.
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Days 1, 2, and 15 during Cycle 1 and Day 1.
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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: Eisai Medical Services, Eisai 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 (Faktiske)
24. september 2007
Primær færdiggørelse (Faktiske)
14. december 2009
Studieafslutning (Faktiske)
13. februar 2017
Datoer for studieregistrering
Først indsendt
29. marts 2006
Først indsendt, der opfyldte QC-kriterier
29. marts 2006
Først opslået (Skøn)
31. marts 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Cetuximab
Andre undersøgelses-id-numre
- E7820-A001-204
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .
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