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
NCT ID: NCT04312282
Last Updated: 2021-07-28
Study Results
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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TERMINATED
PHASE1
93 participants
INTERVENTIONAL
2020-03-06
2021-06-15
Brief Summary
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Detailed Description
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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 receive tesetaxel on Day 1 of two 21-day cycles under fed and fasting conditions in one of two opposing sequences (Sequence 1A and Sequence 1B).
Cohort 2:
Cohort 2 is a 2-period, single-sequence, crossover study designed to assess the potential PK drug-drug interaction (DDI) of a strong CYP3A inhibitor (itraconazole) on tesetaxel and tesetaxel metabolites. Patients receive tesetaxel during Cycle 1 followed by a reduced dose of tesetaxel plus itraconazole during Cycle 2.
Cohort 3:
Cohort 3 is a 2-period, single-sequence, crossover study designed to assess the potential PK DDI of a strong CYP3A inducer (rifampin) on tesetaxel and tesetaxel metabolites. Patients receive tesetaxel during Cycle 1 followed by tesetaxel plus rifampin during Cycle 2.
Patients in all cohorts also participate in a study designed to assess the effect of tesetaxel and tesetaxel metabolites on cardiac repolarization as measured by the change from baseline in the QTc interval over the first cycle of treatment. Patients who are tolerating and benefitting from treatment with tesetaxel have the opportunity to continue onto an optional treatment extension.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1, Sequence 1A: Fed then fasted
Cycle 1: Tesetaxel on Day 1 of a 21-day cycle under fed conditions
Cycle 2: Tesetaxel on Day 1 of a 21-day cycle under fasted conditions
Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Cohort 1, Sequence 1B: Fasted then fed
Cycle 1: Tesetaxel on Day 1 of a 21-day cycle under fasted conditions
Cycle 2: Tesetaxel on Day 1 of a 21-day cycle under fed conditions
Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Cohort 2: Tesetaxel plus itraconazole
Cycle 1: Tesetaxel on Day 1 of a 21-day cycle
Cycle 2: Tesetaxel on Day 1 of a 21-day cycle and itraconazole on Day -3 through Day 14 of a 21-day cycle
Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Itraconazole
Itraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle
Cohort 3: Tesetaxel plus rifampin
Cycle 1: Tesetaxel on Day 1 of a 21-day cycle
Cycle 2: Tesetaxel on Day 1 of a 21-day cycle and rifampin on Day -6 through Day 14 of a 21-day cycle
Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Rifampin
Rifampin orally once daily from Day -6 to Day 14 of a 21-day cycle
Interventions
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Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Tesetaxel
Tesetaxel orally on Day 1 of a 21-day cycle
Itraconazole
Itraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle
Rifampin
Rifampin orally once daily from Day -6 to Day 14 of a 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Odonate Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph O'Connell, M.D.
Role: STUDY_DIRECTOR
Odonate Therapeutics, Inc.
Locations
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START Midwest
Grand Rapids, Michigan, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Other Identifiers
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ODO-TE-S101
Identifier Type: -
Identifier Source: org_study_id
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