| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Metastatic Breast Cancer Patients after failure to Anthracyclines, Taxanes and Capecitabine. | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Classification code | 10055113 | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | | To determine the objective response rate of RPR109881 administered as a 1-hour infusion every 3 weeks in patients with metastatic breast cancer relapsing or progressing after therapy with anthracyclines, taxanes, and capecitabine. | |
| E.2.2 | Secondary objectives of the trial | ·To assess the safety and tolerability of RPR109881 in this patient population.
·To assess the impact of RPR109881 on pain control and analgesic use.
·To assess the impact of RPR109881 on the maintenance of performance status.
·To determine the effect of RPR109881 on clinical benefit as assessed by time to tumor response, duration of response, time to tumor progression, and overall survival.
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | . Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic (TxNxM1) or locally recurrent and inoperable (T4NxM0).
. Patients must have been previously treated with an anthracycline, taxanes (docetaxel and/or paclitaxel), and capecitabine. These treatments may have been given in the adjuvant or metastatic setting, separately or combined.
. Patients must not have received more than two previous chemotharapy regimens for metastatic or locally recurrent and inoperable breast cancer.
. Evidence of measurable disease as defined by RECIST.
. Completion of all prior chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), targeted non-cytotoxic therapy, and radiotherapy more or equal 3 weeks prior to first treatment dose on study. Prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable or non-measurable disease being evaluated for efficacy in this protocol. Patients on stable doses of bisphosphonate therapy for at least 90 days prior to first treatment dose on study may continue such therapy.
. ECOG (Eastern Cooperative Oncology Group) performance status of 0,1 or 2.
| |
| E.4 | Principal exclusion criteria | . History of any second malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. Patients with adequately treated contralateral breast cancer which has been disease-free for more than 5 years prior to first treatment dose on study are eligible.
. Concurrent treatment with other anti-cancer therapy, including chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted therapy, or patients planning to receive these treatments.
. Concurrent treatment with potent inhibitors of cytochrome P450 3A4, such as ketoconazole, itraconazole, and clarithromycin, or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required before first treatment dose on study.
. Prior treatment with epothilones or with non-approved tubulin-interacting agents.
. Prior participation in any other trials that involve RPR109881 with a survival endpoint to avoid compromising the results of such trials.
. HER2-positive patients who are candidates for Herceptin®.
. Known symptomatic brain or leptomeningeal involvement with cancer. Patients with a history of symptomatic brain or leptomeningeal involvement with cancer (i) must have had these lesions previously surgically removed or irradiated; (ii) are not being treated currently with corticosteroids; and (iii) have had documentation that the lesions are stable or improving by CT or MRI scan performed at least 3 months apart. CT or MRI scan of the brain is required only in case of clinical suspicion of central nervous system involvement. Patients with asymptomatic untreated brain lesions are not excluded.
. Known human immunodeficiency virus (HIV) infection currently requiring therapy, or acquired immunodeficiency syndrome (AIDS)-related illness.
. Patients who are pregnant or breastfeeding.
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| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary efficacy variable is the Response Rate (RR) defined as the proportion of patients with confirmed CR or confirmed PR, defined by RECIST criteria, relative to the total number of patients in the analysis population. | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description | |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 | The trial involves single site in the Member State concerned | No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | | The duration of this study is expected to take approximately 20 months, which includes the time necessary for the confirmatory radiological study to be performed (no less than 4 weeks after the criteria for response are met initially) on the last patient enrolled who responds after two cycles of therapy and for the determination of stable disease (requering follow-up of 12 weeks or longer) | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
