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

16 maja 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

6

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Inne nazwy:
  • LY3009806
  • IMC-1121B
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2010

Zakończenie podstawowe (Rzeczywisty)

1 października 2011

Ukończenie studiów (Rzeczywisty)

1 października 2011

Daty rejestracji na studia

Pierwszy przesłany

2 grudnia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 grudnia 2010

Pierwszy wysłany (Oszacować)

3 grudnia 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 czerwca 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 maja 2014

Ostatnia weryfikacja

1 maja 2014

Więcej informacji

Terminy związane z tym badaniem

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Ramucirumab (IMC-1121B )

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