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Résztvevőt keres itt: Kína1. fázis

A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

A legfontosabb adatok

Ki végzi
Pfizer
Hol
Changsha, Chengdu, Guangzhou, Nanjing és Wenzhou (Kína)Mind a 6 helyszín megnézéseMég 7 másik országban, 81 helyszínen
Állapot
Toboroz
Fázis
1. fázis
Résztvevők
453 fő, tervezett
Kezdés
2018. ápr. 17.
Várható befejezés
2029. júl. 7.
A vizsgálat típusa
Beavatkozással járó, 10 csoport
A vizsgált kezelések
  • Mevrometostat (PF-06821497)
  • Enzalutamide
  • Itraconazole
A regiszteradat frissítve
2026. november 13.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 17 feltétel megnézéseKevesebb

Egyéb feltételek

  • Part 1 and Part 2 (Closed for enrollment)
  • Part 3 Key Inclusion Criteria:
  • Histological or cytological diagnosis of castration resistant prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months
  • Adequate bone marrow, renal, and liver function; Part 3 Key Exclusion Criteria:
  • Prior irradiation to >25% of the bone marrow
  • QTcF interval >480 msec at screening
  • Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy)
  • Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery
  • Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inducers or inhibitors
  • Prior enzalutamide within the last 4 weeks
  • DDI SUBSTUDY:
  • history of CHF or evidence of ventricular dysfunction
  • fructose intolerance
  • coadministration of CYP3A4 substrates
  • Any history of prior malignancies, except for carcinoma in situ or non-melanoma skin cancer, prior non-hematologic malignancies >= 3 years before randomization with no subsequent recurrence or progression, Stage 0 or 1 non-hematologic cancer < 3 years before randomization that has a remote probability of recurrence or progression

Helyszínek itt: Kína

Még 7 másik országban, 81 helyszínen

  • Hunan Cancer HospitalChangsha, KínaNo longer taking part
  • West China Hospital，Sichuan UniversityChengdu, KínaRésztvevőt keres
  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, KínaNo longer taking part
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, KínaNo longer taking part
  • Zhongda Hospital Southeast UniversityNanjing, KínaNo longer taking part
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, KínaNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.

A teljes eredeti leírásKevesebb

Part 3, which is open for enrollment is seeking men who:

* have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment

All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).

In the assessment phase:

* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule. * participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule.

After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.

The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.

A vizsgálat 10 csoportja

  • Dose Escalation (Part 1A)A vizsgált kezelés

    Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels

    Kezelés: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 1B)A vizsgált kezelés

    Participants with FL will receive mevrometostat at escalating dose levels

    Kezelés: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 1C)A vizsgált kezelés

    Participants with mCRPC will receive mevrometostat at escalating dose levels.

    Kezelés: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 2A)A vizsgált kezelés

    Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.

    Kezelés: Mevrometostat (PF-06821497) és Enzalutamide

  • Dose Expansion (Part 2B)A vizsgált kezelés

    Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.

    Kezelés: Mevrometostat (PF-06821497) és Enzalutamide

  • Japan CohortA vizsgált kezelés

    Participants with CRPC will receive mevrometostat at one or two doses

    Kezelés: Mevrometostat (PF-06821497)

  • China cohortA vizsgált kezelés

    Participants will receive mevrometostat at one or two doses

    Kezelés: Mevrometostat (PF-06821497)

  • Dose Expansion (Part 2C)A vizsgált kezelés

    Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC

    Kezelés: Mevrometostat (PF-06821497) és Enzalutamide

  • BE SubstudyA vizsgált kezelés

    In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.

    Kezelés: Mevrometostat (PF-06821497) és Enzalutamide

  • DDI SubstudyA vizsgált kezelés

    The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.

    Kezelés: Mevrometostat (PF-06821497), Enzalutamide és Itraconazole

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)
A regiszteradat frissítve
2026. november 13.