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Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas

16. května 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

6

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Japonsko
      • Chiba, Japonsko, 277-8577
        • ImClone Investigational Site
      • Osaka, Japonsko, 569-8686
        • ImClone Investigational Site
      • Osaka, Japonsko, 589-5811
        • ImClone Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
Biologický: Ramucirumab (IMC-1121B )
8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Ostatní jména:
  • LY3009806
  • IMC-1121B
Lék: Paclitaxel
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Časové okno: Cycle 1 of 28-day cycle
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.
Cycle 1 of 28-day cycle
Number of Participants With Adverse Events (AEs)
Časové okno: Up to 47 weeks post baseline
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.
Up to 47 weeks post baseline
Number of Participants With Serious Adverse Events (SAEs)
Časové okno: Up to 47 weeks post baseline
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.
Up to 47 weeks post baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Časové okno: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Cmax after a single dose of ramucirumab (IMC-1121B).
Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Časové okno: Cycle 1 through Cycle 5 (28-day cycles)
The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
Cycle 1 through Cycle 5 (28-day cycles)
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Časové okno: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 1
Časové okno: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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).
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) or Cycle 1
Časové okno: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Časové okno: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Časové okno: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Cmax after multiple doses of ramucirumab (IMC-1121B).
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Časové okno: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 2
Časové okno: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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).
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 2
Časové okno: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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).
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Časové okno: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Časové okno: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Časové okno: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 3
Časové okno: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 3
Časové okno: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Časové okno: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Časové okno: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Časové okno: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 4
Časové okno: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 4
Časové okno: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eli Lilly and Company

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2010

Primární dokončení (Aktuální)

1. října 2011

Dokončení studie (Aktuální)

1. října 2011

Termíny zápisu do studia

První předloženo

2. prosince 2010

První předloženo, které splnilo kritéria kontroly kvality

2. prosince 2010

První zveřejněno (Odhad)

3. prosince 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

18. června 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. května 2014

Naposledy ověřeno

1. května 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 14204
  • CP12-1026 (Jiný identifikátor: ImClone Systems)
  • I4T-IE-JVBW (Jiný identifikátor: Eli Lilly and Company)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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