Breast NeoplasmPhase 2NCT01221870
Tesetaxel as First-line Therapy for Metastatic Breast Cancer
A Phase 2 study testing Tesetaxel once every 3 weeks and Tesetaxel once weekly in people with Breast Neoplasm, run by Genta Incorporated at 4 sites in United States.
Trial summary
The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Tesetaxel once every 3 weeks and Tesetaxel once weekly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2010to Jan 2013
- 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
Primary Inclusion Criteria:
- Female
- At least 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage IV disease
- HER2 status negative
- Measurable disease (revised RECIST; Version 1.1)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Life expectancy of at least 3 months
- Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
- Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
- Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
- Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
- Ability to swallow an oral solid-dosage form of medication
Primary Exclusion Criteria:
- Known metastasis to the central nervous system
- History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
- Significant medical disease other than Stage IV breast cancer
- Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- History of hypersensitivity to a taxane
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 3 recruiting
- Recruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Joyce O'Shaughnessy, MD, joyce.oshaughnessy@usoncology.com
Joyce O'Shaughnessy, MD
- Recruiting
The Moses H. Cone Regional Cancer Center
Greensboro, North Carolina, 27403
Peter Rubin, MD, 336-832-1100
Peter Rubin, MD
- Active, not recruiting
The West Clinic
Memphis, Tennessee, 38120
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Andrew D Seidman, MD, 646-888-4559
Andrew D Seidman, MD
About this study
Official title: A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer
The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.
Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.
- Conditions
- Breast Neoplasm
- Being tested
- Tesetaxel once every 3 weeks, Tesetaxel once weekly
- Keywords
- Metastatic breast cancer, First-line therapy, Tesetaxel, Oral taxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesetaxel once every 3 weeksDrug
Also called DJ-927
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
Tesetaxel once weeklyDrug
Also called DJ-927
Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel once every 3 weeks | Experimental | Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months Receives: Drug: Tesetaxel once every 3 weeks |
| Tesetaxel once weekly | Experimental | Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months Receives: Drug: Tesetaxel once weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (revised RECIST)
Proportion of patients with a confirmed complete or partial response
Measured: 12 months from date of first dose of study medication for last patient enrolled
Secondary outcomes (6)
Disease control rate
Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
Measured: 12 months from date of first dose of study medication for last patient enrolled
Progression-free rate
Proportion of patients without disease progression 6 months following the first dose of study medication
Measured: 6 months from date of first dose of study medication for last patient enrolled
Durable response rate
Proportion of patients with a confirmed complete or partial response ≥ 6 months in duration
Measured: 12 months from date of first dose of study medication for last patient enrolled
Duration of response
Date when response criteria are first met to the date when progression is first documented
Measured: 12 months from date of first dose of study medication for last patient enrolled
Time to progression
Date of first dose of study medication to the date when progression is first documented
Measured: 12 months from date of first dose of study medication for last patient enrolled
Adverse events
Incidence of adverse events
Measured: Up to 30 days after the last dose of study medication for a specific patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT01221870
- Sponsor's protocol ID
- TOB203
- Status last verified
- Jul 2012
- First submitted
- 13 Oct 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
- A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01221870
- Acronym / sponsor ID
- TOB203
- Conditions
- Breast Neoplasm
- Keywords
- Metastatic breast cancer, First-line therapy, Tesetaxel, Oral taxane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 15 Oct 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.
The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.
Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel once every 3 weeks | Experimental | Drug: Tesetaxel once every 3 weeksTesetaxel 27 mg/m2 orally once every 21 days for up to 12 months |
| Tesetaxel once weekly | Experimental | Drug: Tesetaxel once weeklyTesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| Tesetaxel once every 3 weeksAlso: DJ-927Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months | Drug | Tesetaxel once every 3 weeks |
| Tesetaxel once weeklyAlso: DJ-927Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months | Drug | Tesetaxel once weekly |
Primary outcome
Response rate (revised RECIST)
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Proportion of patients with a confirmed complete or partial response
6 secondary outcomes
Disease control rate
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Progression-free rate
Time frame: 6 months from date of first dose of study medication for last patient enrolled
Durable response rate
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Duration of response
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Time to progression
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Adverse events
Time frame: Up to 30 days after the last dose of study medication for a specific patient
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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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.
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, United States
Andrew D Seidman, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites 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 once every 3 weeks and Tesetaxel once weekly in people with Breast Neoplasm, run by Genta Incorporated at 4 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?
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 4 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 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 (revised RECIST) (time frame: 12 months from date of first dose of study medication for last patient enrolled). 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.