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Ponatinib in Advanced NSCLC w/ RET Translocations

8. december 2019 opdateret af: Alice Shaw, Massachusetts General Hospital

A Phase II, Open-Label Study of Ponatinib, A Multi-Targeted Oral Tyrosine Kinase Inhibitor, in Advanced Non-Small Cell Lung Cancer Harboring RET Translocations

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied.

It has been found that some people with NSCLC have a change (mutation) in a certain gene called the RET gene. This mutated gene may help cancer cells grow. Only participants with a RET mutation will be allowed to participate. In this study, investigators are testing the strategy of using a study drug designed to inhibit or shut off growth signals that results from the mutated RET gene.

Ponatinib is an anti-cancer drug that has been used in research studies for other types of cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this research study, investigators are looking to see whether ponatinib is effective and safe in treating NSCLC harboring RET rearrangements.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Participants in this research study will be asked to undergo some screening tests or procedures to confirm that eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that participants do not take part in the research study. These tests and procedures include the following: medical history, vital signs, physical exam, performance status, electrocardiogram, echocardiogram, routine blood tests, pregnancy test and an assessment of tumor by CT or MRI. If these tests show that a participant is eligible to participate in the research study, he/she will begin the study treatment. If a patient does not meet the eligibility criteria, he/she will not be able to participate in this research study.

Participants will take the study drug once a day, every day of the cycle. Each treatment cycle lasts 28 days (4 weeks). Participants will be given a drug diary to record the drug they take each day. The diary will also include special instructions for taking the study drug.

For cycles 1-20, participants will visit the clinic to have tests and procedures done at the time points listed here: On Day 1-physical exam, vital signs, performance status, electrocardiogram, routine blood tests, pharmacokinetic test, clinical exam and assessment of tumor. On day 15 of cycle 1-vital signs, routine blood tests and clinical exam.

For cycles 11 and on, participants will visit the clinic every 6 weeks. Some of these visits will happen on Day 1 of the cycle and some of these visits will happen on Day 15 of the cycle. At each visit, the following tests and procedures will be done: physical exam, vital signs, performance status, electrocardiogram, routine blood tests, clinical exam, and an assessment of your tumor.

Participants will visit the clinic when their study doctor takes them off study drug permanently. They will also visit the clinic 30 days after stop taking the study drug. The following tests and procedures will be done: physical exam, vital signs, performance status, electrocardiogram, routine blood tests, pregnancy test, clinical exam and a tumor assessment.

Investigators would also like to keep track of participant's medical condition for two years after their first study dose. Investigators will contact participants by telephone every 3 months. If participants still come to the clinic, visits might be used as contact.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

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
    • California
      • Orange, California, Forenede Stater, 92868
        • University of California, Irvine
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater
        • Karmanos Cancer Institute
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University

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:

  • Histologically or cytologically confirmed advanced NSCLC
  • Molecular confirmation of a RET translocation
  • At least one measurable lesion as defined by RECIST
  • No restriction on number of prior therapies
  • Estimated life expectancy of at least 12 weeks
  • Able to swallow and retain orally administered medication
  • Must agree to use an effective form of contraception from enrollment through 30 days after the end of study treatment
  • Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria:

  • Clinically significant gastrointestinal abnormalities
  • Pregnant or breastfeeding
  • Major surgery within 28 days of initiating therapy
  • History of CNS disease (Note: Participants with brain metastases will be eligible if treated appropriately and if they remain clinically stable).
  • Anti-cancer therapy within 3 weeks
  • History of significant bleeding disorder unrelated to cancer
  • History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
  • History of alcohol abuse
  • Uncontrolled hypertriglyceridemia
  • History of arterial thrombotic events (myocardial infarction, stroke or peripheral vascular disease).
  • Uncontrolled hypertension
  • Taking medications that are known to be associated with Torsades de Pointes
  • Ongoing active infection
  • Diagnosed with or received anti-cancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or in situ cancers)
  • Any condition or illness tha could compromise patient safety or interfere with the evaluation of the drug

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: Ponatinib Treatment Arm
Ponatinib 30 mg PO daily
Medicin: Ponatinib
28 day cycle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: From the start of treatment until disease progression or death, up to approximately 2 years

The number of participants that achieved either a partial or complete response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)

  • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.
  • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From the start of treatment until disease progression or death, up to approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Control Rate
Tidsramme: From the start of treatment until disease progression or death, up to approximately 2 years

The number of participants that achieved either a partial or complete response or stable disease, assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)

  • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.
  • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
From the start of treatment until disease progression or death, up to approximately 2 years
Median Progression-Free Survival
Tidsramme: From study entry until disease progression or death, median duration of 3.8 months

The duration of time from study entry until disease progression (assessed using RECIST 1.1.) or death.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.
From study entry until disease progression or death, median duration of 3.8 months
1 Year Overall Survival Rate
Tidsramme: 1 year
The number of participants surviving one year after study entry
1 year
Number of Participants With Adverse Events
Tidsramme: From the start of treatment until 30 days after the end of treatment (up to approximately 2 years)
The number of participants with grade 3 plus adverse events as assessed using Common Toxicology Criteria for Adverse Events (CTCAE 4) that were deemed to be possibly, probably, or definitely related to study treatment.
From the start of treatment until 30 days after the end of treatment (up to approximately 2 years)

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

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.

Generelle publikationer

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. september 2013

Primær færdiggørelse (Faktiske)

1. juni 2018

Studieafslutning (Faktiske)

1. august 2018

Datoer for studieregistrering

Først indsendt

13. marts 2013

Først indsendt, der opfyldte QC-kriterier

14. marts 2013

Først opslået (Skøn)

19. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-103

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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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner