- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327743
Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer
April 18, 2016 updated by: Sanofi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France
- Sanofi-Aventis Administrative Office
-
-
-
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.)
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: larotaxel + Capecitabine
|
IV infusion on Day 1 of a 21-day cycle
Other Names:
oral, twice daily, Day 1-Day 14 of a 21-day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine
Time Frame: study period
|
study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response in patients with measurable disease
Time Frame: study period
|
study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 4, 2006
First Submitted That Met QC Criteria
May 16, 2006
First Posted (Estimate)
May 18, 2006
Study Record Updates
Last Update Posted (Estimate)
May 18, 2016
Last Update Submitted That Met QC Criteria
April 18, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCD6511
- EudraCT:2006-006474-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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