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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. října 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

90

Fáze

  • Fáze 2

Kontakty a umístění

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

Studijní místa

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

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

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

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: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
Biologický: Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Biologický: 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
Ostatní jména:
  • Erbitux
Lék: 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
Ostatní jména:
  • Taxol
  • Abraxane
  • Nov-Onxol
  • Onxol
Lék: 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
Ostatní jména:
  • Paraplatin
Aktivní komparátor: Control
Cetuximab + Paclitaxel/Carboplatin
Biologický: 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
Ostatní jména:
  • Erbitux
Lék: 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
Ostatní jména:
  • Taxol
  • Abraxane
  • Nov-Onxol
  • Onxol
Lék: 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
Ostatní jména:
  • Paraplatin

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS) in Each Study Arm Based on the Safety Population
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

HiberCell, Inc.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Folker Schneller, MD, Technical University, Munich

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. srpna 2009

Primární dokončení (Aktuální)

1. listopadu 2012

Dokončení studie (Aktuální)

1. srpna 2015

Termíny zápisu do studia

První předloženo

1. dubna 2009

První předloženo, které splnilo kritéria kontroly kvality

2. dubna 2009

První zveřejněno (Odhad)

3. dubna 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

29. listopadu 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. října 2016

Naposledy ověřeno

1. října 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BT-CL-PGG-LCA0822

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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