Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02703571
Phase
PHASE1
Status
Terminated

Conditions

  • Colorectal Cancer for Phase II
  • Pancreatic Cancer for Phase II
  • Solid Tumors for Phase Ib

Eligibility Criteria

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

Interventions

  • ribociclib — DRUG
    Combination treatment with LEE and TMT
  • Trametinib — DRUG
    Combination treatment with LEE and TMT

Study Details

Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.

Key Dates

Start date
Jun 29, 2016
Status verified
Sep 2020
Primary completion
Sep 24, 2019
Completion
Sep 24, 2019

Study Design

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

Arms

  • Experimental: Advanced or metastatic solid tumors
    Patients in the Phase I portion of the study who have advanced or metastatic solid tumors

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: 21-day cycle one of treatment ]

Locations (6)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
City of Hope National Medical CenterDuarteCalifornia91010-
Yale University School of MedicineNew HavenConnecticut06520-
University of Miami Sylvester Comp Cancer CtrMiamiFlorida33136-
Dana Farber Cancer CenterBostonMassachusetts02215-
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Fayetteville, AR

By research site
Highlands Oncology Group· Fayetteville, ARCity of Hope National Medical Center· Duarte, CAYale University School of Medicine· New Haven, CTUniversity of Miami Sylvester Comp Cancer Ctr· Miami, FLDana Farber Cancer Center· Boston, MAUT MD Anderson Cancer Center· Houston, TX