Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT02555189
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IV Prostate Cancer AJCC v7

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enzalutamide — DRUG
    Given PO
  • Ribociclib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enzalutamide with ribociclib may be safe, tolerable and/or effective in treating metastatic, castrate-resistant, chemotherapy naive prostate cancer that retains retinoblastoma expression.

Key Dates

Start date
Dec 1, 2015
Status verified
Mar 2026
Primary completion
Dec 7, 2022
Completion
Sep 1, 2023

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: 200 mg Ribociclib + Enzalutamide
    Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 200 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
  • Experimental: Phase I: 400 mg Ribociclib + Enzalutamide
    Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 400 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
  • Experimental: Phase I: 600 mg Ribociclib + Enzalutamide
    Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 600 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
  • Active Comparator: Phase II: Enzalutamide Only
    Patients receive Enzalutamide 160mg PO QD once daily on Days 1-28 of each 28-day cycle. This is one of two randomized arms in the Phase II portion. Treatment continues until disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
  • Experimental: Ribociclib at RP2D + Enzalutamide
    Patients receive Ribociclib 600mg PO QD once daily on Days 1-21 of each 28-day cycle in combination with Enzalutamide 160mg PO QD once daily. This is one of two randomized arms in the Phase II portion. Patients will continue treatment until disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.

Primary Outcome Measure

Number of Dose Limiting Toxicity of Ribociclib (Phase IB) [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIRoswell Park Cancer Institute· Buffalo, NYMemorial Sloan Kettering Cancer Center· New York, NYThomas Jefferson University· Philadelphia, PA

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