PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

Part of paid clinical trials in Goshen, Indiana.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT04887194
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • Sitravatinib — DRUG
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
  • Warfarin — DRUG
    CYP2C9 probe substrate
  • Dextromethorphan — DRUG
    CYP2D6 probe substrate
  • Midazolam — DRUG
    CYP3A4 probe substrate
  • Digoxin — DRUG
    P-gp probe substrate
  • Rosuvastatin — DRUG
    BCRP probe substrate
  • Nivolumab — DRUG
    Nivolumab is a programmed death receptor (PD-1) blocking antibody

Study Details

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Key Dates

Start date
Apr 8, 2021
Status verified
May 2024
Primary completion
Dec 22, 2022
Completion
Dec 22, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1, Part 1: Sitravatinib monotherapy (DDI cohort)
    To evaluate the potential for drug-drug interactions (DDI) with sitravatinib monotherapy. To determine the effect of sitravatinib on the pharmacokinetics (PK) of midazolam (CYP3A4 probe substrate), warfarin (CYP2C9 probe substrate), dextromethorphan (CYP2D6 probe substrate), rosuvastatin (BCRP probe substrate), and digoxin (P-gp probe substrate).
  • Experimental: Phase 1, Part 1: Sitravatinib monotherapy (QTc cohort)
    To evaluate the QTc prolongation risk for sitravatinib in patients with advanced/metastatic solid tumors via C-QTc modeling.
  • Experimental: Phase 1, Part 2: Combination Therapy (both DDI and QTc cohorts)
    To evaluate safety and tolerability of Sitravatinib treatment with the addition of the checkpoint inhibitor nivolumab.

Primary Outcome Measure

PK parameters of probe drugs; AUC from time zero to the last data point (AUC-last) [ Time Frame: Part 1; 1-20 Days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Goshen HealthGoshenIndiana46526-
NEXT OncologyAustinTexas78758-
NEXT OncologySan AntonioTexas78229-
NEXT OncologyFairfaxVirginia22031-
MultiCare Health SystemTacomaWashington98402-

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