- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01253525
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
16. maj 2014 opdateret af: Eli Lilly and Company
A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
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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Chiba, Japan, 277-8577
- ImClone Investigational Site
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Osaka, Japan, 569-8686
- ImClone Investigational Site
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Osaka, Japan, 589-5811
- ImClone Investigational Site
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy
- Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy.
- Has adequate organ function
- Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication
Exclusion Criteria:
- Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date
- Has elective or planned surgery to be conducted during the trial
- Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy
- Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C
- Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date
- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date
- Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date
- Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted]
- Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date
- Has a history of GI perforation and/or fistulae within 6 months prior to the study date
- Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
- Has uncontrolled arterial hypertension despite standard medical management.
- Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date
- Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Has a serious illness or medical condition(s)
- Is pregnant or lactating
- Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date
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: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
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8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Andre navne:
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Tidsramme: Cycle 1 of 28-day cycle
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DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation.
SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.
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Cycle 1 of 28-day cycle
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Number of Participants With Adverse Events (AEs)
Tidsramme: Up to 47 weeks post baseline
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The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
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Up to 47 weeks post baseline
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Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Up to 47 weeks post baseline
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The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
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Up to 47 weeks post baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Tidsramme: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Tidsramme: Cycle 1 through Cycle 5 (28-day cycles)
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The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
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Cycle 1 through Cycle 5 (28-day cycles)
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Tidsramme: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Clearance (CL) or Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
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Ramucirumab Clearance (CL) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Half-Life (t 1/2) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
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Ramucirumab Half-Life (t 1/2) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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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
1. november 2010
Primær færdiggørelse (Faktiske)
1. oktober 2011
Studieafslutning (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først indsendt
2. december 2010
Først indsendt, der opfyldte QC-kriterier
2. december 2010
Først opslået (Skøn)
3. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14204
- CP12-1026 (Anden identifikator: ImClone Systems)
- I4T-IE-JVBW (Anden identifikator: Eli Lilly and Company)
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 .