Resumen

Los investigadores desean evaluar si MK-5684 (el medicamento del estudio) puede tratar el cáncer de mama, el cáncer de ovario y el cáncer de endometrio. MK-5684 está diseñado para tratar el cáncer bloqueando la producción de hormonas esteroideas en el organismo. Los investigadores compararán MK-5684 con los tratamientos estándar para cada tipo de cáncer en este estudio. El objetivo de este estudio es determinar si las personas que reciben MK-5684 viven más tiempo sin que el cáncer crezca o se disemine en comparación con las personas que reciben un tratamiento estándar.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Cohort A:
Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.
Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting.
Cohort B:
Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \[carcinosarcoma\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.
Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.
Cohort C:
Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \[FIGO\] Grade 1/2, or well/moderately differentiated).
Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting.
All Cohorts :
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Criterios de exclusión

Cohort A:
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
Cohort B:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \[1L\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
Cohort C:
Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
All Cohorts:
Has confirmed or suspected adrenal metastases.
Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
Has any prior history or current condition of adrenal insufficiency.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of stem cell/solid organ transplant.
Has not adequately recovered from major surgery or has ongoing surgical complications.

Intervenciones

drug

Opevesostat

Tablet for oral administration.

drug

Fludrocortisone/ Fludrocortisone acetate

Tablet for oral administration.

drug

Dexamethasone/Dexamethasone acetate

Tablet for oral administration.

drug

Rescue Medications

Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.

drug

Fulvestrant

Administered via intramuscular injection.

drug

Exemestane

Tablet for oral administration.

drug

Megestrol acetate/Medroxyprogesterone acetate

Tablet for oral administration.

drug

Tamoxifen

Tablet for oral administration.

drug

Letrozole

Tablet for oral administration.

Ubicaciones

Hospital Aleman ( Site 0301)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +5491148277000

RECRUITING

Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +541147815331

RECRUITING

Instituto Alexander Fleming ( Site 0303)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +541132218900

RECRUITING

Estudio en cesta de fase 2, multicéntrico, abierto, de MK-5684 en participantes con tumores sólidos seleccionados (OMAHA-015)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Opevesostat

Fludrocortisone/ Fludrocortisone acetate

Dexamethasone/Dexamethasone acetate

Rescue Medications

Fulvestrant

Exemestane

Megestrol acetate/Medroxyprogesterone acetate

Tamoxifen

Letrozole

Ubicaciones

Hospital Aleman ( Site 0301)

Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)

Instituto Alexander Fleming ( Site 0303)

Patrocinadores

Contactos

Toll Free Number