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

• Status: Terminated
• Trial end date: 2021-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odonate Therapeutics, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole; Rifampin

Criteria

Inclusion Criteria:

• Female or male patients at least 18 years of age

• Histologically or cytologically confirmed solid tumor

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Adequate cardiac conduction by ECG

• Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• Presence of risk factors for QTc prolongation

• Presence of neuropathy Grade > 1

• Anticancer treatment ≤ 14 days prior to randomization

• Major surgery ≤ 28 days prior to randomization

• Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of:

• A moderate or strong inhibitor or inducer of CYP3A

• A CYP3A substrate with a narrow therapeutic range or that is contraindicated with either itraconazole or rifampin