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.

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

Advanced Solid Tumor

Part 1 of this study is designed to evaluate the potential for drug-drug interactions and
QTc effects with sitravatinib monotherapy when administered with probe drugs for specific
cytochrome P450 (CYP) enzymes (CYP2C9, CYP2D6, and CYP3A4) and P-glycoprotein (P-gp) and
breast cancer resistance protein (BCRP) transporters

Part 2 allows for patients to continue sitravatinib treatment with the addition of the
checkpoint inhibitor Nivolumab.

Sitravatinib

Warfarin

Dextromethorphan

Midazolam

Digoxin

Rosuvastatin

Nivolumab

A Two-cohort, Two-part, Phase 1, Multicenter, Open-label, Fixed-sequence, Drug-Drug Interaction and QTc Assessments of Sitravatinib Followed by Combination Treatment With Nivolumab in Patients With Advanced Solid Malignancies

(warfarin, dextromethorphan, midazolam, digoxin, and rosuvastatin) derived from the
plasma concentration time profile before and after oral administration of sitravatinib

Characterization of AEs by incidence, severity, timing, seriousness & relationship to
study treatment

Safety characterized by type, incidence, severity, timing, seriousness & relationship to
study treatment of adverse events, and laboratory abnormalities

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).

To evaluate the QTc prolongation risk for sitravatinib in patients with
advanced/metastatic solid tumors via C-QTc modeling.

To evaluate safety and tolerability of Sitravatinib treatment with the addition of the
checkpoint inhibitor nivolumab.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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