Solid TumorsPhase 1NCT01170975
Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
A Phase 1 study testing Tesetaxel 10 mg with and then without food and Tesetaxel 10 mg without and then with food in people with Solid Tumors, run by Genta Incorporated at 1 site in United States.
Trial summary
This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Tesetaxel 10 mg with and then without food and Tesetaxel 10 mg without and then with food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 18 and 75 years of age.
- Histologically or cytologically confirmed advanced solid tumor malignancy.
- Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential.
- Agreement to use a highly effective form of contraception throughout the treatment phase of the study in women of childbearing potential and sexually active men.
- Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive.
- 12-lead ECG without any clinically significant abnormality as judged by the Investigator.
- Able to swallow oral medication.
- Adequate organ system function.
Who cannot join
- A positive pre-study hepatitis B surface antigen.
- Symptomatic or acute hepatic or biliary abnormalities.
- Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
- Presence of uncontrolled infection.
- Positive pre-study drug/alcohol screen.
- Treatment with an investigational agent within the following time periods prior to the first dose of study drug: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longest).
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- Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with a subject's safety, obtaining informed consent, or compliance with the study.
- Pregnancy or lactation.
- Hypoalbuminemia (serum albumin <3.0 g/dL) at screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or pummelos, exotic citrus fruits, or grapefruit hybrids within 14 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Researh
Minneapolis, Minnesota, 55404
About this study
Official title: An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects
This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
Read the detailed description
This study is being conducted to determine whether the pharmacokinetics of a single dose of tesetaxel administered as a capsule is affected by co-administration with food (a high-fat meal).
- Conditions
- Solid Tumors
- Being tested
- Tesetaxel 10 mg with and then without food, Tesetaxel 10 mg without and then with food
- Keywords
- Advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesetaxel 10 mg with and then without foodDrug
Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
Tesetaxel 10 mg without and then with foodDrug
Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Other | Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state Receives: Drug: Tesetaxel 10 mg with and then without food |
| Treatment sequence 2 | Other | Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state Receives: Drug: Tesetaxel 10 mg without and then with food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)
Measured: Predose and postdosing up to 36 days after administration of each dose
Secondary outcomes (1)
Safety and tolerability
Adverse events, clinical laboratory tests, vital signs
Measured: From screening through 36 days after administration of the final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry W Alcorn, PharmD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170975
- Sponsor's protocol ID
- TOPK103
- Status last verified
- Jul 2012
- First submitted
- 26 Jul 2010
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects
- ClinicalTrials.gov ID
- NCT01170975
- Acronym / sponsor ID
- TOPK103
- Conditions
- Solid Tumors
- Keywords
- Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Jul 2010 (estimated)
- 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 study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
Detailed description
This study is being conducted to determine whether the pharmacokinetics of a single dose of tesetaxel administered as a capsule is affected by co-administration with food (a high-fat meal).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Other | Drug: Tesetaxel 10 mg with and then without foodTreatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state |
| Treatment sequence 2 | Other | Drug: Tesetaxel 10 mg without and then with foodTreatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects between 18 and 75 years of age.
- Histologically or cytologically confirmed advanced solid tumor malignancy.
- Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential.
- Agreement to use a highly effective form of contraception throughout the treatment phase of the study in women of childbearing potential and sexually active men.
- Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive.
Key exclusion criteria (11 listed)
- A positive pre-study hepatitis B surface antigen.
- Symptomatic or acute hepatic or biliary abnormalities.
- Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
- Presence of uncontrolled infection.
- Positive pre-study drug/alcohol screen.
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 |
|---|---|---|
| Tesetaxel 10 mg with and then without foodTreatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state | Drug | Treatment sequence 1 |
| Tesetaxel 10 mg without and then with foodTreatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state | Drug | Treatment sequence 2 |
Primary outcome
Pharmacokinetic parameters
Time frame: Predose and postdosing up to 36 days after administration of each dose
Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)
1 secondary outcome
Safety and tolerability
Time frame: From screening through 36 days after administration of the final dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Harry W Alcorn, PharmD principal investigator
Davita Clinical Research
1 site 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 10 mg with and then without food and Tesetaxel 10 mg without and then with food in people with Solid Tumors, run by Genta Incorporated at 1 site 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic parameters (time frame: Predose and postdosing up to 36 days after administration of each dose). 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 24 Jul 2012.