Locally Advanced Non-resectable Breast CancerPhase 2NCT01609127
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing Tesetaxel and Capecitabine in people with Locally Advanced Non-resectable Breast Cancer and Metastatic Breast Cancer, run by Genta Incorporated at 1 site in United States.
Trial summary
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Tesetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2014
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- At least 18 years of age
- Locally advanced non-resectable or metastatic breast cancer
- HER2 negative disease
- Measurable disease per revised RECIST, Version 1.1
- Eastern Cooperative Oncology Group performance status 0 or 1
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- Chemotherapy naïve, OR 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. If the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended.
- Documented disease recurrence or progression
- Adequate bone marrow, hepatic, and renal function
- Ability to swallow an oral solid-dosage form of medication
- Written informed consent
Who cannot join
- Known metastasis to the central nervous system
- Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
- Significant medical disease other than breast cancer
- Presence of neuropathy > Grade 1 (NCI CTC)
- History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
- History of severe or unexpected reaction to fluoropyrimidine therapy
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- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
- Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The West Clinic
Memphis, Tennessee, 38120
Tracy B Stewart, RN, BSN, OCN, CCRC, 901 683-0055 ext. 1236, tstewart@WESTCLINIC.com
Lee S Schwartzberg, MD, FACP
About this study
Official title: A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.
- Being tested
- Tesetaxel, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-day cycle
TesetaxelDrug
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 of each 28-day cycle
CapecitabineDrug
Also called Xeloda
Capecitabine 1250 mg/m2 orally twice daily (in the morning and evening after a meal; equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel every 3 weeks | Experimental | Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle Receives: Drug: Tesetaxel |
| Tesetaxel weekly | Experimental | Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle Receives: Drug: Tesetaxel |
| Capecitabine | Active comparator | Capecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST [Version 1.1])
Measured: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized
Secondary outcomes (4)
Clinical benefit rate
the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months
Measured: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
Progression-free survival
the period from the date of randomization to the date when disease progression is first documented or when the patient dies within 6 weeks of the last lesion assessment
Measured: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
Progression-free survival rate
the percentage of patients who are progression free
Measured: 6 and 12 months after patients' date of randomization
Adverse events
the percentage of patients with adverse events classified by term and body system
Measured: up to 30 days after patients' 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 posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-resectable Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew D Seidman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609127
- Sponsor's protocol ID
- TOB206
- Status last verified
- May 2012
- First submitted
- 25 May 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01609127
- Acronym / sponsor ID
- TOB206
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 May 2012 (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 conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel every 3 weeks | Experimental | Drug: TesetaxelTesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle |
| Tesetaxel weekly | Experimental | Drug: TesetaxelTesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle |
| Capecitabine | Active comparator | Drug: CapecitabineCapecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- At least 18 years of age
- Locally advanced non-resectable or metastatic breast cancer
- HER2 negative disease
- Measurable disease per revised RECIST, Version 1.1
Key exclusion criteria (10 listed)
- Known metastasis to the central nervous system
- Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
- Significant medical disease other than breast cancer
- Presence of neuropathy > Grade 1 (NCI CTC)
- History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
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 27 mg/m2 orally once on Day 1 of each 21-day cycle | Drug | Tesetaxel every 3 weeks |
| TesetaxelTesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 of each 28-day cycle | Drug | Tesetaxel weekly |
| CapecitabineAlso: XelodaCapecitabine 1250 mg/m2 orally twice daily (in the morning and evening after a meal; equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 of each 21-day cycle | Drug | Capecitabine |
Primary outcome
Response rate
Time frame: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized
the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST [Version 1.1])
4 secondary outcomes
Clinical benefit rate
Time frame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
Progression-free survival
Time frame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
Progression-free survival rate
Time frame: 6 and 12 months after patients' date of randomization
Adverse events
Time frame: up to 30 days after patients' last dose of study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Andrew D Seidman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesetaxel and Capecitabine in people with Locally Advanced Non-resectable Breast Cancer and Metastatic Breast Cancer, 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 11 inclusion and 10 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 1 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response rate (time frame: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized). 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 1 Jun 2012.