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Phase 2 Study of Oral IXAZOMIB in Adult Participants With Relapsed and/or Refractory Follicular Lymphoma

7 października 2019 zaktualizowane przez: Millennium Pharmaceuticals, Inc.

An Open-label, Multicenter, Phase 2 Study of Oral IXAZOMIB (MLN9708) in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma

The primary purpose of this study is to evaluate the anti-tumor activity of oral Ixazomib as measured by overall response rate (ORR) in adult participants with relapsed and/or refractory follicular lymphoma (FL).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

29

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Belgia
      • Gent, Belgia
      • Leuven, Belgia
      • Wilrijk, Belgia
  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada
  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone
    • New York
      • New York, New York, Stany Zjednoczone
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone
    • Texas
      • Houston, Texas, Stany Zjednoczone
  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo
      • Manchester, Zjednoczone Królestwo
      • Newcastle Upon Tyne, Zjednoczone Królestwo
      • Plymouth, Zjednoczone Królestwo
      • Southampton, Zjednoczone Królestwo
      • Sutton, Zjednoczone Królestwo

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:

  • Male or female participants 18 years or older.
  • Participants must have a pathologically confirmed diagnosis of non-Hodgkin lymphoma (NHL) (for the lead-in dose-finding phase) and FL (for phase 2).
  • Participants must have radiographically or clinically measurable disease.
  • Participants must be relapsed and/or refractory after at least 1 prior therapy (excluding radiation) with documented progressive disease at the time of enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence.
  • Male participants who agree to practice effective barrier contraception or agree to practice true abstinence.
  • Voluntary written consent.
  • Suitable venous access.
  • Appropriate clinical laboratory values as defined in the protocol.
  • Recovered from toxicities of prior anticancer therapy.
  • If the trial proceeds to the second step on the basis of the tandem 2-step design, participants must be confirmed PSMB1 positive at the central laboratory before treatment.

Exclusion Criteria

  • Peripheral neuropathy that is greater or equal to Grade 2 or Grade 1 with pain.
  • Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
  • Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time.
  • Major surgery within 14 days before the first dose of study drug.
  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
  • Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participants inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Evidence of current uncontrolled cardiovascular conditions including uncontrolled hypertension, severe uncontrolled ventricular arrhythmias, unstable angina, New York Heart Association (NYHA) Class III or IV cardiac disease, or myocardial infarction within the past 6 months.
  • Diarrhea greater than (>) Grade 1 on the basis of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
  • Systemic antineoplastic (including glucocorticoids > the equivalent of 15 mg of prednisone daily), experimental, or radiation therapy within 21 days before the first dose of study drug.
  • Prior treatment with rituximab or other unconjugated antibody treatment within 42 days (21 days if clear evidence of progressive disease or immediate treatment is mandated).
  • Treatment with radioimmunoconjugates or toxin immunoconjugates within 12 weeks before the first dosing of study treatment.
  • Systemic treatment with strong inhibitors of Cytochrome P450 1A2 (CYP1A2) or Cytochrome P450 3A (CYP3A), or strong CYP3A inducers within 14 days before the first dose of IXAZOMIB - Ongoing systemic therapy with corticosteroids.
  • Central nervous system (CNS) involvement that is clinically uncontrolled or newly diagnosed in the last 4 months.
  • Ongoing or active systemic viral infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus or known active hepatitis C virus.
  • Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ.
  • Platelet transfusions within 3 days before the 1st dose of study drug.
  • Inability to swallow capsules, or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medication for 2 hours before and 1 hour after dose of IXAZOMIB - Known allergy to boron or excipients in the formulation.

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: IXAZOMIB
Ixazomib 4, 5.3 and 7 milligram (mg), orally, once on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days, for up to Cycle 29 or until disease progression or unacceptable toxicity at lead-in phase for participants with NHL. After completion of lead-in phase, participants will continue into Phase 2. Participants in Phase 2 will receive Ixazomib at RP2D dose, orally, once weekly on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days , for up to Cycle 29 or until disease progression or unacceptable toxicity in Phase 2 for participants with RRFL.
Lek: IXAZOMIB
Each 28-day treatment cycle will include oral administration of IXAZOMIB on Days 1, 8, and 15 followed by a rest period of 13 days.
Inne nazwy:
  • MLN9708

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Overall Response Rate (ORR)
Ramy czasowe: Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using the international Working Group criteria for participants CR: disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Lead-in Dose Finding Phase: Recommended Phase 2 Dose (RP2D)
Ramy czasowe: Baseline up to Cycle 1 Day 28
Baseline up to Cycle 1 Day 28
Progression Free Survival (PFS)
Ramy czasowe: Time from the date of first dose of study treatment to the date of first documented PD or death (approximately up to Day 802)
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death. Participants without documentation of PD will be censored at the date of last response assessment that is SD or better. Participants without response assessment will be censored at the date of first dose.
Time from the date of first dose of study treatment to the date of first documented PD or death (approximately up to Day 802)
Phase 2: Rate of Disease Control
Ramy czasowe: Baseline or until occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 805)
Rate of disease control is defined as percentage of participants who achieved a SD or better for greater than or equal to (>=) 6 months.
Baseline or until occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 805)
Time to Response (TTR)
Ramy czasowe: Time from the date of first dose of study treatment to the date of first documented PR or better response or death (approximately up to Day 802)
TTR is defined as the time from the date of first dose of study treatment to the date of the first documentation of a PR or better response in a participant who responded.
Time from the date of first dose of study treatment to the date of first documented PR or better response or death (approximately up to Day 802)
Duration of Response (DOR)
Ramy czasowe: Time from the date of first documentation of a response to the date of first documented PD (approximately up to Day 802)
The DOR is defined as the time from the date of first documentation of a response to the date of first documented PD. Responders without documentation of PD will be censored at the date of last response assessment. DOR was categorized as CR+PR and CR.
Time from the date of first documentation of a response to the date of first documented PD (approximately up to Day 802)
Phase 2: Number of Participants With Response Rates in PSMB1 Positive and PSMB1 Negative
Ramy czasowe: Baseline up to occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 802)
Baseline up to occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 802)
Number of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Ramy czasowe: Baseline up to 30 days after last dose of study drug (approximately up to Day 832)
Baseline up to 30 days after last dose of study drug (approximately up to Day 832)
Lead-in Dose Finding Phase: Cmax: Maximum Observed Plasma Concentration for Ixazomib
Ramy czasowe: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Lead-in Dose Finding Phase: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Ramy czasowe: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Lead-in Dose Finding Phase: AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for Ixazomib
Ramy czasowe: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Millennium Pharmaceuticals, Inc.

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 (Rzeczywisty)

31 października 2013

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2016

Ukończenie studiów (Rzeczywisty)

23 marca 2017

Daty rejestracji na studia

Pierwszy przesłany

28 sierpnia 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 września 2013

Pierwszy wysłany (Oszacować)

11 września 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 października 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 października 2019

Ostatnia weryfikacja

1 października 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • C16017
  • 2013-002302-32 (Numer EudraCT)
  • U1111-1164-7551 (Inny identyfikator: WHO)
  • 166547 (Identyfikator rejestru: HC-CTD)
  • REec-2016-2137 (Identyfikator rejestru: REec)
  • 13/EM/0373 (Identyfikator rejestru: NRES)

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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