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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2022-12-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Two Part, Phase 1 study enrolling patients with advanced tumor types into two cohorts: drug-drug interaction (DDI) and QTc. All patients receive the same anticancer treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

Warfarin

Intervention Type DRUG

CYP2C9 probe substrate

Dextromethorphan

Intervention Type DRUG

CYP2D6 probe substrate

Midazolam

Intervention Type DRUG

CYP3A4 probe substrate

Digoxin

Intervention Type DRUG

P-gp probe substrate

Rosuvastatin

Intervention Type DRUG

BCRP probe substrate

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.

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

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.

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

Nivolumab

Intervention Type DRUG

Nivolumab is a programmed death receptor (PD-1) blocking antibody

Interventions

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Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

Intervention Type DRUG

Warfarin

CYP2C9 probe substrate

Intervention Type DRUG

Dextromethorphan

CYP2D6 probe substrate

Intervention Type DRUG

Midazolam

CYP3A4 probe substrate

Intervention Type DRUG

Digoxin

P-gp probe substrate

Intervention Type DRUG

Rosuvastatin

BCRP probe substrate

Intervention Type DRUG

Nivolumab

Nivolumab is a programmed death receptor (PD-1) blocking antibody

Intervention Type DRUG

Other Intervention Names

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MGCD516 Coumadin Robitussin Versed LANOXICAPS Crestor OPDIVO

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of unresectable advanced/metastatic solid tumor
* Life expectancy of at least 3 months
* Adequate bone marrow and organ function

Exclusion Criteria

* Ongoing medical condition or need for treatment with medication that may affect the PK of study treatments during Part 1
* Immunocompromising conditions
* Impaired heart function
* Active or prior documented autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No