Advanced Solid TumorsPhase 1NCT01337310
Study of Tesetaxel in Japanese Patients With Solid Tumors
A Phase 1 study testing Tesetaxel in people with Advanced Solid Tumors, run by Genta Incorporated at 1 site in Japan.
Trial summary
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Tesetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2011to Sep 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary inclusion criteria:
- At least 20 years of age
- Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed
- ECOG performance status not more than 1
- Adequate bone marrow, hepatic, and renal function
- Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1
- At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1
Primary exclusion criteria:
- Brain metastasis or leptomeningeal disease
- Significant medical disease other than cancer
- Neuropathy greater than Grade 1
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kinki University School of Medicine
Osaka-fu, 589-8511
Takayasu Kurata, MD, PhD, +81-72-366-0221
Takayasu Kurata, MD, PhD
About this study
Official title: A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.
- Conditions
- Advanced Solid Tumors
- Being tested
- Tesetaxel
- Keywords
- Advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Also called DJ-927
The starting dose for the first 3 patients treated will be 24 mg/m2. In the absence of dose-limiting toxicity, the dose will be increased by 3 mg/m2 for the next group of 3 patients treated. Interpatient dose escalation will continue in this manner to 27 and 31 mg/m2 until the maximum tolerated dose or the maximum dose allowed per protocol (31 mg/m2) is reached and 6 patients are treated at this dose.
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel | Experimental | Tesetaxel administered orally once every 21 days for at least 2 cycles Receives: Drug: Tesetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
Measured: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Secondary outcomes (3)
Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme)
Measured: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Percentage of patients with adverse events
Measured: Through 30 days after the last dose of tesetaxel
Tumor response rate
Measured: After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012 (estimated)
- Study completionSep 2012 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337310
- Sponsor's protocol ID
- TOPK106
- Status last verified
- Mar 2012
- First submitted
- 4 Apr 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01337310
- Acronym / sponsor ID
- TOPK106
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 18 Apr 2011 (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.
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel | Experimental | Drug: TesetaxelTesetaxel administered orally once every 21 days for at least 2 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TesetaxelAlso: DJ-927The starting dose for the first 3 patients treated will be 24 mg/m2. In the absence of dose-limiting toxicity, the dose will be increased by 3 mg/m2 for the next group of 3 patients treated. Interpatient dose escalation will continue in this manner to 27 and 31 mg/m2 until the maximum tolerated dose or the maximum dose allowed per protocol (31 mg/m2) is reached and 6 patients are treated at this dose. | Drug | Tesetaxel |
Primary outcome
Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
Time frame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
3 secondary outcomes
Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme)
Time frame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Percentage of patients with adverse events
Time frame: Through 30 days after the last dose of tesetaxel
Tumor response rate
Time frame: After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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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.
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 in people with Advanced Solid Tumors, run by Genta Incorporated at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 13 Mar 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur (time frame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)). 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 13 Mar 2012.