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A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer

6. december 2020 opdateret af: Novartis Pharmaceuticals

A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part:

Dose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):

Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients.

Once the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment.

Safety dose expansion part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):

Patients will be treated with BEZ235, as single agent or in combination with trastuzumab, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

183

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Manchester, Det Forenede Kongerige, M20 9BX
        • Novartis Investigative Site
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • University of California at Los Angeles JonssonComprehensiveCancerCtr
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine YaleCancerCtr-ClinTrialsOffice
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute Clinical Trials ProjectManager
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Nevada Cancer Institute NVCC - Huntsman
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas CCC Faris
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(2)
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Health Care System/Sammons Cancer Center Baylor- Sammons
      • Houston, Texas, Forenede Stater, 77030-4009
        • University of Texas/MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)
      • Tyler, Texas, Forenede Stater, 75702
        • Tyler Cancer Center TCC
  • Holland
      • Amsterdam, Holland, 1066 CX
        • Novartis Investigative Site
  • Spanien
    • Catalunya
      • Barcelona, Catalunya, Spanien, 08035
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spanien, 46010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spanien, 46009
        • Novartis Investigative Site
  • Tyskland
      • Essen, Tyskland, 45147
        • Novartis Investigative Site

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:

[Single agent dose escalation arm]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists.

[Combination part]: Patients with metastatic HER2+ Breast Cancer, after failure of trastuzumab treatment. Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN.

[Single agent safety expansion arm]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. Patients will be prescreened for molecular alterations affecting PIK3CA and/or PTEN. Patients with NSCLC will also be pre-screened for EGFR mutation.

Exclusion Criteria:

  • Patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control
  • Prior treatment with a PI3K inhibitor
  • Acute or chronic liver disease or renal disease
  • Acute or chronic pancreatitis
  • Patients with unresolved diarrhea ≥ CTCAE grade 2
  • Impaired cardiac function or clinically significant cardiac diseases
  • Patients with diabetes mellitus requiring insulin treatment
  • Patients with known coagulopathies
  • Patients with a history of photosensitivity reactions to other drugs
  • Any of the following ophthalmological findings:
  • Progressive eye disease that could lead to severe loss of visual acuity or visual field
  • loss during the study period
  • Inability to perform the ophthalmic procedures required in this protocol
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.

Other protocol-defined inclusion/exclusion criteria may apply

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BEZ235 Alone, Dose Escalation
Medicin: BEZ235
Eksperimentel: BEZ235 + trastuzumab, Dose Escalation
Medicin: BEZ235
Eksperimentel: BEZ235 Alone, MTD Expansion
Medicin: BEZ235
Eksperimentel: BEZ235 + Trastuzumab, MTD Expansion
Medicin: BEZ235

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
determine the maximum Tolerated Dose (MTD) of BEZ235 as single agent and in combination with trastuzumab (Dose escalation part)
Tidsramme: at end of study
at end of study
assess the safety & tolerability of BEZ235 SDS as single agent and in combination with trastuzumab administered to patients at the MTD level (Safety expansion part)
Tidsramme: at end of study
at end of study

Sekundære resultatmål

Resultatmål
Tidsramme
assess the safety and tolerability of the various formulations of BEZ235
Tidsramme: at end of study
at end of study
Asses the Pharmacokinetics of BEZ235 which includes AUC, Cmax, Tmax, t1/2 as endpoints
Tidsramme: at end of study
at end of study
Preliminary anti-tumor activity (tumor response) of BEZ235 SDS as single agent and in combination with trastuzumab
Tidsramme: end of study
end of study

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

21. december 2006

Primær færdiggørelse (Faktiske)

8. januar 2013

Studieafslutning (Faktiske)

8. januar 2013

Datoer for studieregistrering

Først indsendt

8. februar 2008

Først indsendt, der opfyldte QC-kriterier

20. februar 2008

Først opslået (Skøn)

21. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2020

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CBEZ235A2101
  • 2006-004353-23 (EudraCT nummer)

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 .

Kliniske forsøg med Brystkræft

Kliniske forsøg med BEZ235

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mozambique

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner