Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT03237390
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Ribociclib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.

Key Dates

Start date
Jan 4, 2018
Status verified
Sep 2022
Primary completion
May 17, 2022
Completion
May 17, 2022

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gemcitabine hydrochloride, ribociclib)
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and ribociclib PO QD on days 8-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: Up to 21 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo ClinicRochesterMinnesota55905-

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