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Ponatinib in Advanced NSCLC w/ RET Translocations

8 grudnia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

9

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ponatinib Treatment Arm
Ponatinib 30 mg PO daily
Lek: Ponatinib
28 day cycle

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Response Rate
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Disease Control Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 1 year
The number of participants surviving one year after study entry
1 year
Number of Participants With Adverse Events
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Massachusetts General Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2013

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2018

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2018

Daty rejestracji na studia

Pierwszy przesłany

13 marca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 marca 2013

Pierwszy wysłany (Oszacować)

19 marca 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 grudnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 grudnia 2019

Ostatnia weryfikacja

1 grudnia 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 13-103

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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