Status:
TERMINATED
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
Lead Sponsor:
Odonate Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 cytoch...
Detailed Description
Cohort 1: Cohort 1 is a 2-period, 2-sequence, crossover study designed to assess the effect of food on the PK of tesetaxel and tesetaxel metabolites. Patients were randomized in a 1:2 ratio to receiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04312282
Start Date
March 6 2020
End Date
June 15 2021
Last Update
July 28 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
START Midwest
Grand Rapids, Michigan, United States, 49546
2
Mary Crowley Cancer Research
Dallas, Texas, United States, 75320
3
NEXT Oncology
San Antonio, Texas, United States, 78229