Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT03989115
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • RMC-4630 — DRUG
    RMC-4630 for oral administration
  • Cobimetinib — DRUG
    Cobimetinib for oral administration
  • Drug: Osimertinib — DRUG
    Osimertinib for oral administration

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.

Key Dates

Start date
Jul 2, 2019
Status verified
Feb 2023
Primary completion
Feb 8, 2022
Completion
Feb 8, 2022

Study Design

Enrollment
113 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RMC-4630 and Cobimetinib
    RMC-4630 and Cobimetinib for oral administration
  • Experimental: RMC-4630 and Osimertinib
    RMC-4630 and Osimertinib for oral administration

Primary Outcome Measure

Number of Participants With Adverse Events (AEs). [ Time Frame: AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment. ]

Locations (21)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
City of HopeDuarteCalifornia91010-
UC Irvine - Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UC San Francisco - Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
University of Colorado Cancer CenterAuroraColorado80045-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Ohio State UniversityColumbusOhio43210-
University of Oklahoma - Stephenson Cancer CenterOklahoma CityOklahoma73104-
Providence Cancer Institute, Franz ClinicPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research Institute - Tennessee Oncology, PLLCNashvilleTennessee37203-
Dell Seton Medical Center at University of TexasAustinTexas78712-
Virginia Cancer Specialists (Fairfax) - USORFairfaxVirginia22031-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZCity of Hope· Duarte, CAUC Irvine - Chao Family Comprehensive Cancer Center· Orange, CAUC Davis Comprehensive Cancer Center· Sacramento, CAUC San Francisco - Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, CO

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