Solid TumorPhase 1NCT01315431
A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
A Phase 1 study testing Tesetaxel plus capecitabine in people with Solid Tumor, run by Genta Incorporated at 1 site in United States.
Trial summary
This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tesetaxel plus capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
- Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
- ECOG performance status of 0 or 1
- Adequate bone marrow, hepatic, and renal function
- At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1
Who cannot join
- Brain metastasis or leptomeningeal disease
- Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
- Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
- Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
- Significant medical disease other than cancer
- Neuropathy at least Grade 2
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- Difficulty swallowing
- Malabsorptive disorder
- Need for other anticancer treatment while receiving study medication
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication.
- Pregnancy or lactation
- History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.
- Conditions
- Solid Tumor
- Being tested
- Tesetaxel plus capecitabine
- Keywords
- Solid tumor malignancy, excluding lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesetaxel plus capecitabineDrug
Also called DJ-927, Xeloda
Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14.
At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol.
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel-capecitabine | Experimental | Not described Receives: Drug: Tesetaxel plus capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Percentage of subjects with adverse events
Measured: Through 30 days following the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee S Schwartzberg, MD, FACP, Principal investigator, The West Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315431
- Sponsor's protocol ID
- TOST107
- Status last verified
- Jul 2012
- First submitted
- 11 Mar 2011
- 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
- A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01315431
- Acronym / sponsor ID
- TOST107
- Conditions
- Solid Tumor
- Keywords
- Solid tumor malignancy, excluding lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 15 Mar 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.
This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel-capecitabine | Experimental | Drug: Tesetaxel plus capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
- Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
- ECOG performance status of 0 or 1
- Adequate bone marrow, hepatic, and renal function
Key exclusion criteria (12 listed)
- Brain metastasis or leptomeningeal disease
- Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
- Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
- Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
- Significant medical disease other than cancer
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 plus capecitabineAlso: DJ-927, XelodaStudy medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14. At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol. | Drug | Tesetaxel-capecitabine |
Primary outcome
Incidence of adverse events
Time frame: Through 30 days following the last dose of study medication
Percentage of subjects with adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
Lee S Schwartzberg, MD, FACP principal investigator
The West Clinic
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 plus capecitabine in people with Solid Tumor, 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 6 inclusion and 12 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: status not confirmed, 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?
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?
Incidence of adverse events (time frame: Through 30 days following the last dose of study medication). 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.