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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04312282

Run by

Odonate Therapeutics, Inc.

People needed

93

Starts

2020-03-06

Expected to finish

2021-06-15

Last updated by the study team

2021-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• START Midwest — Grand Rapids, Michigan, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.