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Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

6 ottobre 2016 aggiornato da: HiberCell, Inc.

Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer

The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
      • Berlin, Germania
        • Helios Clinic Emil von Behring
      • Frankfurt, Germania
        • Municipal Clinic Frankfurt Hoescht
      • Gottingen, Germania, 37075
        • Georg-August University Göttingen
      • Heidelberg, Germania
        • University Clinical Heidelberg
      • Minden, Germania
        • Clinic Minden
      • Munich, Germania
        • Techincal University of Munich
      • Nuremberg, Germania
        • Clinic Nurnberg Nord
      • Ulm, Germania, 89081
        • Universitätsklinikum Ulm
      • Wuppertal, Germania, 42283
        • HELIOS Klinikum Wuppertal, Medizinische Klinik 1
  • Stati Uniti
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30912
        • Medical College of Georgia
    • Indiana
      • Terre Haute, Indiana, Stati Uniti, 47802
        • Providence Medical Group
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota
    • Texas
      • Dallas, Texas, Stati Uniti, 75201
        • Mary Crowley Medical Research Center
      • Midland, Texas, Stati Uniti, 79701
        • Allison Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
  2. Is between the ages of 18 and 75 years old, inclusive
  3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
  4. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
  5. Has an ECOG performance status of 0 or 1
  6. Has a life expectancy of > 3 months

  7. Has adequate hematologic function as evidenced by:

    • ANC ≥ 1,500/μL
    • PLT ≥ 100,000/μL
    • HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;

  8. Has adequate renal function as evidenced by:

    • Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
    • Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;

  9. Has adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ 1.0 mg/dL
    • AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
    • ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
  10. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.

Exclusion Criteria:

  1. Has received prior systemic chemotherapy at any time for lung cancer;
  2. Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
  3. Has a known hypersensitivity to baker's yeast, or has an active yeast infection
  4. Has had previous exposure to Betafectin® or Imprime PGG
  5. Has an active infection

  6. Presents with any of the following medical diagnoses/conditions at the time of screening:

    • Central nervous system (CNS) metastases
    • Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
    • Peripheral neuropathy ≥ grade 2 from any cause
    • Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
    • Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation

  7. Has a history of any of the following medical diagnoses/conditions:

    • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
    • Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
  8. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
  9. Has a know sensitivity to Cremophor EL
  10. Has previously received treatment with cetuximab
  11. If female, is pregnant or breast-feeding
  12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
  13. Has previously received an organ or progenitor/stem cell transplant.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
Biologico: Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Biologico: Cetuximab
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Altri nomi:
  • Erbitux
Droga: Paclitaxel
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Altri nomi:
  • Tassolo
  • Abraxane
  • Nov-Onxol
  • Onxol
Droga: Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Altri nomi:
  • Paraplatino
Comparatore attivo: Control
Cetuximab + Paclitaxel/Carboplatin
Biologico: Cetuximab
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Altri nomi:
  • Erbitux
Droga: Paclitaxel
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Altri nomi:
  • Tassolo
  • Abraxane
  • Nov-Onxol
  • Onxol
Droga: Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Altri nomi:
  • Paraplatino

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Lasso di tempo: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) in Each Study Arm Based on the Safety Population
Lasso di tempo: From the time of randomization to death, subject being lost to follow-up or study completion
Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.
From the time of randomization to death, subject being lost to follow-up or study completion
Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
Lasso di tempo: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Lasso di tempo: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
Lasso di tempo: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
Lasso di tempo: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.

If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.
From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

HiberCell, Inc.

Investigatori

  • Investigatore principale: Folker Schneller, MD, Technical University, Munich

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2009

Completamento primario (Effettivo)

1 novembre 2012

Completamento dello studio (Effettivo)

1 agosto 2015

Date di iscrizione allo studio

Primo inviato

1 aprile 2009

Primo inviato che soddisfa i criteri di controllo qualità

2 aprile 2009

Primo Inserito (Stima)

3 aprile 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BT-CL-PGG-LCA0822

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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