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Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

18. september 2017 opdateret af: Ahmad Tarhini
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Steubenville, Ohio, Forenede Stater, 43952
        • UPMC Cancer Center - Teramana Cancer Center - Steubenville
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • UPMC Cancer Center - Beaver
      • Clairton, Pennsylvania, Forenede Stater, 15025
        • UPMC Cancer Center - Clairton
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • UPMC Cancer Center - Oakbrook Commons - Greensburg
      • Indiana, Pennsylvania, Forenede Stater, 15701
        • UPMC Cancer Center - Indiana
      • Johnstown, Pennsylvania, Forenede Stater, 15901
        • UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
      • McKeesport, Pennsylvania, Forenede Stater, 15132
        • UPMC Cancer Center - McKeesport
      • Monroeville, Pennsylvania, Forenede Stater, 15146
        • UPMC Cancer Center - Monroeville
      • Moon, Pennsylvania, Forenede Stater, 15108
        • UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group
      • New Castle, Pennsylvania, Forenede Stater, 16105
        • UPMC Cancer Center - New Castle
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh Cancer Institute - Hillman Cancer Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15215
        • UPMC Cancer Center - St. Margaret's
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • UPMC Cancer Center - Passavant
      • Pittsburgh, Pennsylvania, Forenede Stater, 15241
        • UPMC Cancer Center - Upper St. Clair
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
        • UPMC Cancer Center - Mercy
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • UPMC Cancer Center - Uniontown
      • Washington, Pennsylvania, Forenede Stater, 15301
        • UPMC Cancer Center - Washington
      • Wexford, Pennsylvania, Forenede Stater, 15090
        • UPMC Cancer Center - North Hills

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded.
  2. Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779).
  3. Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
  4. ECOG performance status 0-2.
  5. A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents.
  6. No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation.
  7. Patients with a prior malignancy should have at least 3 years of disease-free survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer or other in situ malignancies are allowed.
  8. No other coexisting medical condition that would preclude full compliance with the study.

  9. Required laboratory values (obtained < 1 week prior to enrollment):

    • ANC >/= 1500/mm³
    • Platelets >/= 100,000/mm³
    • AST and ALT ≤ 3 x ULN (upper limits of normal). In patients with liver metastases AST and ALT should be < 5 x ULN.
    • Total bilirubin up to 1.5 x ULN (upper limits of normal).
  10. Age >/= 18 years and capacity to give informed consent.
  11. Patients should be advised to discontinue drugs that interact with CYP3A4 (see list of examples in Table 3.1 of the full protocol), if medically safe.
  12. All patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  1. Prior treatment with any investigational agent within the preceding 4 weeks.
  2. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
  3. A known history of HIV seropositivity.
  4. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
  5. Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin).
  6. Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk.
  7. Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
  8. Patients should not be on chronic systemic glucocorticoids or other immunosuppressant.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RAD001 (Everolimus)
RAD001 (Everolimus)10 mg by mouth daily without interruption
Medicin: RAD001 (everolimus)
10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Andre navne:
  • Certican®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.
Tidsramme: Two cycles of treatment with RAD001 (~6 weeks)
Two cycles of treatment with RAD001 (~6 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: From entry in trial to up to 60 months
From entry in trial to up to 60 months
Progression-free Survival
Tidsramme: From entry into trial to up to 60 months
From entry into trial to up to 60 months
Objective Response Rate
Tidsramme: From beginning of treatment up to 60 months
Number of patients for which response to treatment was observed / total number of patients.
From beginning of treatment up to 60 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ahmad Tarhini

Samarbejdspartnere

Novartis Pharmaceuticals

Efterforskere

  • Ledende efterforsker: Ahmad Tarhini, MD, PhD, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2006

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

6. september 2006

Først indsendt, der opfyldte QC-kriterier

6. september 2006

Først opslået (Skøn)

8. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 06-049

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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