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The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors

NCT04312282 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-07-28

No results posted yet for this study

Summary

This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.

Conditions

Interventions

DRUG

Tesetaxel

Tesetaxel orally on Day 1 of a 21-day cycle

DRUG

Tesetaxel

Tesetaxel orally on Day 1 of a 21-day cycle

DRUG

Itraconazole

Itraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle

DRUG

Rifampin

Rifampin orally once daily from Day -6 to Day 14 of a 21-day cycle

Sponsors & Collaborators

  • Odonate Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph O'Connell, M.D. · Odonate Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2020-09-30
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312282 on ClinicalTrials.gov