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

16. Mai 2014 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Interventionell

Einschreibung (Tatsächlich)

6

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Andere Namen:
  • LY3009806
  • IMC-1121B
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2010

Primärer Abschluss (Tatsächlich)

1. Oktober 2011

Studienabschluss (Tatsächlich)

1. Oktober 2011

Studienanmeldedaten

Zuerst eingereicht

2. Dezember 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Dezember 2010

Zuerst gepostet (Schätzen)

3. Dezember 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

18. Juni 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Mai 2014

Zuletzt verifiziert

1. Mai 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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