Metastatic Breast Cancer MedDRA version: 8.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 183133-96-2
Current Sponsor code: RPR116258A
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent. Patients with previously treated histo/cytologically confirmed disease who develop clinical or radiological evidence of metastatic disease do not require separate confirmation of the metastatic disease. 2. All patients must have received an anthracycline and a taxane prior to entry in the protocol. These drugs may have been given in the neoadjuvant/adjuvant or in the metastatic setting, may have been given concurrently or sequentially, and may have been given in combination with other drugs. Patients should have received a standard dose of anthracycline and of taxane expected to have potentially resulted in a response. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The following breast cancer treatments: a. Patients having received more than one adjuvant regimen. However, patients who have received neoadjuvant therapy immediately followed by surgery and immediately followed by adjuvant therapy without intervening progression are considered to have received one adjuvant regimen and are allowed in the trial. b. Patients having received more than one chemotherapy regimen for metastatic or locally recurrent and inoperable breast cancer. A chemotherapy regimen is defined as a single or a combination of chemotherapy agents given until documented disease progression or relapse. For example, patients who received sequential doxorubicin and docetaxel in the metastatic setting without intervening progression are allowed in the trial as this is considered one CT regimen. - ECOG performance status (PS)>2. - Absence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). For the part 1 component, patients with non-measurable disease are accepted. - Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement). - Patients with known intolerance to fluoropyrimidines or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. - Concurrent treatment with strong 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. - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: *Part 1: - To determine the Maximum Administered Dose (MAD) and the Dose Limiting Toxicities (DLTs) of XRP6258 administered as a 1-hour infusion every 3 weeks in combination with capecitabine tablets twice daily for 2 weeks in 3-week cycles, in patients (pts) with metastatic breast cancer (MBC) progressing after anthracycline and taxane. - To determine the Maximum Tolerated Dose (MTD) of XRP6258 in combination with capecitabine, in pts with MBC, progressing after anthracycline and taxane. The MTD, (determined once the MAD has been reached in the part 1), will be used in the part 2 of the study to assess the antitumor response. *Part 2: - To determine the antitumor activity of XRP6258 in combination with capecitabine, in an additional cohort of pts with MBC progressing after anthracycline and taxane, as assessed by objective response rate (ORR) according to RECIST.;Secondary Objective: - To assess the safety profile of the combination regimen of XRP6258 with capecitabine. - To assess the pharmacokinetics (PK) of XRP6258 and its metabolite RPR123142, and of capecitabine and its metabolite 5-FU and to evaluate any PK drug-drug interaction between the compounds following this schedule of administration. - To determine the Time To Progression (TTP) and duration of response (DR), of the extended cohort of pts treated at the MTD in the part 2 of the study.;Primary end point(s): - In the part 1, DLTs at cycle 1 of the combination of XRP6258 and capecitabine. - In the part 2, efficacy will be determined using objective responses (CR and PR) as assessed by investigators according to RECIST criteria. Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI) 4-6 weeks after the first radiological documentation of response. | — |
Countries
Belgium
Outcome results
None listed