- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02597036
A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors
16. oktober 2020 opdateret af: Eli Lilly and Company
A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors
The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors.
The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
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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Brussel, Belgien, 1000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology PLLC
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Nashville, Tennessee, Forenede Stater, 37203
- SMO Sarah Cannon Research Inst.
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Villejuif, Frankrig, 94805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spanien, 08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Have a diagnosis of cancer that is advanced and/or metastatic.
- Have disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST ) version 1.1.
- Have adequate organ function.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have discontinued previous treatments for cancer for at least 28 days or 5 half-lives prior to study enrolment.
Exclusion Criteria:
- Have serious preexisting medical conditions.
- Have received treatment with a drug predominantly targeting Ang2 activity.
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- Have current hematologic malignancies.
- Have an active fungal, bacterial, and/or known viral infection.
- Have a corrected QT interval using Fridericia's correction (QTcF) of >470 msec on screening electrocardiogram (ECG) at several consecutive days of assessment.
- Have a known sensitivity to mAbs or other therapeutic proteins.
- Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
- Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 3 months prior to receiving treatment.
- Receive anticoagulation therapy at therapeutic dose.
- Have experienced any arterial or venothrombotic or thromboembolic events within 6 months prior to study treatment.
- Have liver cirrhosis with a Child-Pugh class B or worse or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
- The participant is pregnant prior to randomization or breastfeeding.
- The participant has sensory peripheral neuropathy ≥ Grade 2 (Part E only).
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Part A LY3127804
Dose escalation of LY3127804 given intravenously (IV) every 2 weeks (Q2W) for 28 day cycle.
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Administreret IV
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Eksperimentel: Part B LY3127804 + Ramucirumab Dose 1
Dose escalation of LY3127804 in combination with Ramucirumab given IV Q2W for 28 day cycle.
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Administreret IV
Andre navne:
Administreret IV
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Eksperimentel: Part C LY3127804 + Ramucirumab Dose 2
LY3127804 in combination with Ramucirumab given IV Q2W for 28 day cycle.
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Administreret IV
Andre navne:
Administreret IV
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Eksperimentel: Part D LY3127804 + Ramucirumab
LY3127804 and Ramucirumab given IV Q2W until participant qualifies for study discontinuation.
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Administreret IV
Andre navne:
Administreret IV
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Eksperimentel: Part E LY3127804 + Ramucirumab + Paclitaxel
LY3127804 and Ramucirumab given IV Q2W and Paclitaxel given IV on day 1, 8, and 15 until participant qualifies for study discontinuation.
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Administreret IV
Andre navne:
Administreret IV
Administreret IV
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of Participants with Dose Limiting Toxicities (DLTs)
Tidsramme: Baseline through Cycle 1 (28 Day Cycle)
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Baseline through Cycle 1 (28 Day Cycle)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Maximum Total Dose (MTD) of LY3127804 Monotherapy and in Combination with Ramuricumab +/- Paclitaxel
Tidsramme: Baseline through Cycle 1 (28 Day Cycle)
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Baseline through Cycle 1 (28 Day Cycle)
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Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3127804
Tidsramme: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
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Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
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Pharmacokinetics: AUC of Ramucirumab in Combination with LY3127804 +/- Paclitaxel
Tidsramme: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
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Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
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Number of Participants with Anti-LY3127804 Antibodies
Tidsramme: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
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Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
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Number of Participants with Anti-Ramucirumab Antibodies
Tidsramme: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
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Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
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Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Tidsramme: Baseline through Measured Progressive Disease or Death (Estimated up to 4 Months)
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Baseline through Measured Progressive Disease or Death (Estimated up to 4 Months)
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Progression Free Survival (PFS)
Tidsramme: Baseline to Measured Progressive Disease or Death (Estimated up to 4 Months)
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Baseline to Measured Progressive Disease or Death (Estimated up to 4 Months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
6. november 2015
Primær færdiggørelse (Faktiske)
23. november 2017
Studieafslutning (Faktiske)
24. maj 2020
Datoer for studieregistrering
Først indsendt
3. november 2015
Først indsendt, der opfyldte QC-kriterier
3. november 2015
Først opslået (Skøn)
4. november 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. oktober 2020
Sidst verificeret
15. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15580
- I7W-MC-JQBA (Anden identifikator: Eli Lilly and Company)
- 2015-001204-64 (EudraCT nummer)
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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