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A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

17. Dezember 2014 aktualisiert von: Eli Lilly and Company

A Phase 2, Open-label Study of IMC-1121B in Combination With Paclitaxel and Carboplatin as First-line Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated.

Angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. It is the physiological process involving the growth of new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. This may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival.

Ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

41

Phase

  • Phase 2

Kontakte und Standorte

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

Studienorte

  • Vereinigte Staaten
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • ImClone Investigational Site
      • San Francisco, California, Vereinigte Staaten, 94143
        • ImClone Investigational Site
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • ImClone Investigational Site
    • New York
      • Bronx, New York, Vereinigte Staaten, 10467
        • ImClone Investigational Site
      • New York, New York, Vereinigte Staaten, 10016
        • ImClone Investigational Site
    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • ImClone Investigational Site
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98104
        • ImClone Investigational Site
  • Vereinigtes Königreich
      • Cambridge, Vereinigtes Königreich
        • ImClone Investigational Site
      • London, Vereinigtes Königreich
        • 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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC
  • Advanced NSCLC
  • Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.0])
  • Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1
  • Age ≥ 18 years
  • Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)
  • Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)
  • Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or trace)
  • Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN
  • Adequate contraception
  • Signed informed consent

Exclusion Criteria:

  • Untreated CNS metastases
  • Prior bevacizumab therapy
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Prior systemic chemotherapy for Stage IIIB/IV NSCLC
  • Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior
  • Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix
  • Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
  • Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Uncontrolled thrombotic or hemorrhagic disorders
  • Poorly-controlled hypertension
  • Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
  • History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)
  • Serious non-healing wound, ulcer, or bone fracture
  • Undergone major surgery or subcutaneous venous access device placement. Post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months
  • Elective or a planned major surgery to be performed during the course of the trial
  • Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])
  • If female, is pregnant or lactating
  • Radiographic evidence of intratumor cavitation
  • Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry

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 + paclitaxel + carboplatin

Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle).

In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.
Biologisch: Ramucirumab
10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.
Andere Namen:
  • LY3009806
  • IMC-1121B
Arzneimittel: Paclitaxel
200 milligrams per meter squared (mg/m^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.
Arzneimittel: Carboplatin
Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Who Are Progression-free (PFS) at 6 Months
Zeitfenster: 6 months
Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Summary of Participants Reporting Adverse Events
Zeitfenster: Baseline up to 32.5 months
Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.
Baseline up to 32.5 months
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])
Zeitfenster: First dose to measured progressive disease or death due to any cause up to 32.5 months
Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
First dose to measured progressive disease or death due to any cause up to 32.5 months
Duration of Response
Zeitfenster: First dose up to 32.5 months
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
First dose up to 32.5 months
Overall Survival (OS) at 1 Year
Zeitfenster: First dose to 1 year
Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.
First dose to 1 year
Progression-free Survival (PFS)
Zeitfenster: First dose to measured progressive disease or death due to any cause, up to 32.5 months

Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.

Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy.
First dose to measured progressive disease or death due to any cause, up to 32.5 months
Overall Survival (OS)
Zeitfenster: First dose to death due to any cause, up to 32.5 months
Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.
First dose to death due to any cause, up to 32.5 months
Serum Anti-Ramucirumab Antibody Assessment
Zeitfenster: Week 15 (Cycle 5)
The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.
Week 15 (Cycle 5)
Maximum Concentration of Ramucirumab (Cmax)
Zeitfenster: Week 18 (Cycle 6), at 1-Hour Post End of Infusion
Week 18 (Cycle 6), at 1-Hour Post End of Infusion

Mitarbeiter und Ermittler

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

Sponsor

Eli Lilly and Company

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. Januar 2009

Primärer Abschluss (Tatsächlich)

1. Oktober 2011

Studienabschluss (Tatsächlich)

1. Januar 2012

Studienanmeldedaten

Zuerst eingereicht

13. August 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. August 2008

Zuerst gepostet (Schätzen)

15. August 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

29. Dezember 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Dezember 2014

Zuletzt verifiziert

1. Dezember 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 13914
  • 2007-006715-22 (EudraCT-Nummer)
  • CP12-0708 (Andere Kennung: ImClone Systems)
  • I4T-IE-JVBJ (Andere Kennung: Eli Lilly and Company)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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