Advanced Solid TumorsPhase 1NCT04312282
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
A Phase 1 study testing Tesetaxel, Itraconazole and Rifampin in people with Advanced Solid Tumors, run by Odonate Therapeutics, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Tesetaxel, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Mar 2020to 15 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mary Crowley Cancer Research
Dallas, Texas, 75320
START Midwest
Grand Rapids, Michigan, 49546
NEXT Oncology
San Antonio, Texas, 78229
About this study
Official title: An Open-Label Study of 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
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.
Read the 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 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
- Advanced Solid Tumors
- Being tested
- Tesetaxel, Itraconazole, Rifampin
- Keywords
- tesetaxel, itraconazole, rifampin, food effect, QTc interval, food-drug interaction, drug-drug interaction, PK, tesetaxel metabolites, advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Tesetaxel orally on Day 1 of a 21-day cycle
TesetaxelDrug
Tesetaxel orally on Day 1 of a 21-day cycle
ItraconazoleDrug
Itraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle
RifampinDrug
Rifampin orally once daily from Day -6 to Day 14 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Sequence 1A: Fed then fasted | Experimental | 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 Receives: Drug: Tesetaxel |
| Cohort 1, Sequence 1B: Fasted then fed | Experimental | 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 Receives: Drug: Tesetaxel |
| Cohort 2: Tesetaxel plus itraconazole | Experimental | 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 Receives: Drug: Tesetaxel; Drug: Itraconazole |
| Cohort 3: Tesetaxel plus rifampin | Experimental | 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 Receives: Drug: Tesetaxel; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cohorts: The change from baseline in Fridericia's corrected QT (ΔQTcF) interval
Measured: Approximately 3 weeks
Cohort 1, Sequences 1A and 1B: Maximum observed plasma concentration (Cmax) for tesetaxel under fed and fasted conditions
Measured: Approximately 6 weeks
Cohort 1, Sequences 1A and 1B: Area under the plasma concentration-time curve from 0 to the last measurable plasma concentration (AUC0-t) for tesetaxel under fed and fasted conditions
Measured: Approximately 6 weeks
Cohort 2: Cmax for tesetaxel in the presence and absence of itraconazole
Measured: Approximately 6 weeks
Cohort 2: AUC from 0 to 336 hours (AUC0-336h) for tesetaxel in the presence and absence of itraconazole
Measured: Approximately 6 weeks
Cohort 3: Cmax for tesetaxel in the presence and absence of rifampin
Measured: Approximately 6 weeks
Cohort 3: AUC0-336h for tesetaxel in the presence and absence of rifampin
Measured: Approximately 6 weeks
Secondary outcomes (3)
All Cohorts: Cmax for tesetaxel metabolites
Measured: Approximately 6 weeks
All Cohorts: AUC for tesetaxel metabolites
Measured: Approximately 6 weeks
All Cohorts: Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs)
Measured: Baseline through 30 days after last administration of Study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start6 Mar 2020
- Primary completion30 Sep 2020
- Study completion15 Jun 2021
Why it stopped: The Sponsor has discontinued the development of tesetaxel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odonate Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph O'Connell, M.D., Study director, Odonate Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312282
- Sponsor's protocol ID
- ODO-TE-S101
- Status last verified
- Jul 2021
- First submitted
- 13 Mar 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of 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
- ClinicalTrials.gov ID
- NCT04312282
- Acronym / sponsor ID
- ODO-TE-S101
- Conditions
- Advanced Solid Tumors
- Keywords
- tesetaxel, itraconazole, rifampin, food effect, QTc interval, food-drug interaction, drug-drug interaction, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has discontinued the development of tesetaxel
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Odonate Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Sequence 1A: Fed then fasted | Experimental | Drug: TesetaxelCycle 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 |
| Cohort 1, Sequence 1B: Fasted then fed | Experimental | Drug: TesetaxelCycle 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 |
| Cohort 2: Tesetaxel plus itraconazole | Experimental | Drug: Tesetaxel, Drug: ItraconazoleCycle 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 |
| Cohort 3: Tesetaxel plus rifampin | Experimental | Drug: Tesetaxel, Drug: RifampinCycle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesetaxelTesetaxel orally on Day 1 of a 21-day cycle | Drug | Cohort 1, Sequence 1A: Fed then fasted |
| TesetaxelTesetaxel orally on Day 1 of a 21-day cycle | Drug | Cohort 1, Sequence 1B: Fasted then fed, Cohort 2: Tesetaxel plus itraconazole, Cohort 3: Tesetaxel plus rifampin |
| ItraconazoleItraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle | Drug | Cohort 2: Tesetaxel plus itraconazole |
| RifampinRifampin orally once daily from Day -6 to Day 14 of a 21-day cycle | Drug | Cohort 3: Tesetaxel plus rifampin |
Primary outcome
All Cohorts: The change from baseline in Fridericia's corrected QT (ΔQTcF) interval
Time frame: Approximately 3 weeks
Cohort 1, Sequences 1A and 1B: Maximum observed plasma concentration (Cmax) for tesetaxel under fed and fasted conditions
Time frame: Approximately 6 weeks
Cohort 1, Sequences 1A and 1B: Area under the plasma concentration-time curve from 0 to the last measurable plasma concentration (AUC0-t) for tesetaxel under fed and fasted conditions
Time frame: Approximately 6 weeks
Cohort 2: Cmax for tesetaxel in the presence and absence of itraconazole
Time frame: Approximately 6 weeks
Cohort 2: AUC from 0 to 336 hours (AUC0-336h) for tesetaxel in the presence and absence of itraconazole
Time frame: Approximately 6 weeks
Cohort 3: Cmax for tesetaxel in the presence and absence of rifampin
Time frame: Approximately 6 weeks
Cohort 3: AUC0-336h for tesetaxel in the presence and absence of rifampin
Time frame: Approximately 6 weeks
3 secondary outcomes
All Cohorts: Cmax for tesetaxel metabolites
Time frame: Approximately 6 weeks
All Cohorts: AUC for tesetaxel metabolites
Time frame: Approximately 6 weeks
All Cohorts: Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs)
Time frame: Baseline through 30 days after last administration of Study treatment
Results and safety
The study was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph O'Connell, M.D. study director
Odonate Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tesetaxel, Itraconazole and Rifampin in people with Advanced Solid Tumors, run by Odonate Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cohorts: The change from baseline in Fridericia's corrected QT (ΔQTcF) interval (time frame: Approximately 3 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.