Breast CancerPhase 1/2NCT00327743
Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing larotaxel and capecitabine in people with Breast Cancer and Cancer, run by Sanofi at 2 sites in 2 countries.
Trial summary
The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer
- What is being tested?
- larotaxel and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Mar 2009
- Phase
- Phase 1/2
- 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
- Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent.
- Prior treatment with a standard regimen of anthracycline and taxane.
- Female patients at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Adequate organ and bone marrow function
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (For the part I component, patients with non-measurable disease are accepted.)
Show all 10Show fewer
- Resolution of all clinically significant toxic effects
- Completion of all prior therapy ≥ 3 weeks prior to registration. Patients on bisphosphonate therapy may continue such therapy.
- Patients must be either post-menopausal, surgically sterile, or using effective contraception.
- Willing and able to comply with study procedures and sign informed consent
Who cannot join
- History of any second malignancy within the last 5 years (except adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri).
- Patients receiving more than one adjuvant regimen or more than one metastatic regimen
- Known brain or leptomeningeal disease.
- Concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapies, or patients planning to receive these treatments during the study.
- Prior treatment with capecitabine, XRP9881, or any investigational chemotherapy.
- History of hypersensitivity to taxanes, Polysorbate-80, or to compounds with similar chemical structures. Patients with known intolerance to fluoropyrimidines or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
Show all 14Show fewer
- Concurrent treatment with potent inhibitors of cytochrome P450 3A4, or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to registration.
- Peripheral neuropathy grade ≥ 2.
- Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4).
- History of inflammatory bowel disease or chronic diarrhea.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation or that may cause undue risk for the patient's safety.
- Known human immunodeficiency virus (HIV) infection requiring treatment or acquired immunodeficiency-syndrome (AIDS)-related illness.
- Patients who are pregnant or breastfeeding.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy
The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.
- Conditions
- Breast Cancer, Cancer
- Being tested
- larotaxel, capecitabine
- Keywords
- Cancer Alternative Therapies, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larotaxelDrug
Also called XRP9881
IV infusion on Day 1 of a 21-day cycle
capecitabineDrug
oral, twice daily, Day 1-Day 14 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| larotaxel + Capecitabine | Experimental | Not described Receives: Drug: larotaxel; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine
Measured: study period
Secondary outcomes (1)
Response in patients with measurable disease
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327743
- Sponsor's protocol ID
- TCD6511
- Other IDs
- EudraCT:2006-006474-21
- Status last verified
- Apr 2016
- First submitted
- 4 May 2006
- Last updated
- 18 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy
- ClinicalTrials.gov ID
- NCT00327743
- Acronym / sponsor ID
- TCD6511
- Conditions
- Breast Cancer, Cancer
- Keywords
- Cancer Alternative Therapies, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 May 2006 (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 goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| larotaxel + Capecitabine | Experimental | Drug: larotaxel, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent.
- Prior treatment with a standard regimen of anthracycline and taxane.
- Female patients at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Adequate organ and bone marrow function
Key exclusion criteria (14 listed)
- History of any second malignancy within the last 5 years (except adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri).
- Patients receiving more than one adjuvant regimen or more than one metastatic regimen
- Known brain or leptomeningeal disease.
- Concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapies, or patients planning to receive these treatments during the study.
- Prior treatment with capecitabine, XRP9881, or any investigational chemotherapy.
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 |
|---|---|---|
| larotaxelAlso: XRP9881IV infusion on Day 1 of a 21-day cycle | Drug | larotaxel + Capecitabine |
| capecitabineoral, twice daily, Day 1-Day 14 of a 21-day cycle | Drug | larotaxel + Capecitabine |
Primary outcome
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine
Time frame: study period
1 secondary outcome
Response in patients with measurable disease
Time frame: study period
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 18 May 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
ICD study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing larotaxel and capecitabine in people with Breast Cancer and Cancer, run by Sanofi at 2 sites in 2 countries.
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 10 inclusion and 14 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. 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 combined 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.
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?
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?
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine (time frame: study 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 18 May 2016.