E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastasic bone pain in patients with breast cancer and bone metastases |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006002 |
E.1.2 | Term | Bone pain |
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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 |
The primary objective to establish the efficacy in pain relief of ibandronic acid, loading dose, in patients with breast cancer and painful metastatic bone disease over a 7-day period. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to describe the safety and tolerance of ibandronic acid based on the monitoring of clinical laboratory results, especially serum creatinine level, creatinine clearance and on spontaneous reporting of adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent - Age ≥ 18 years - Histological or cytological evidence of breast cancer - Presence of bone metastases documented on bone X-ray, CT scan or MRI scan - Mean pain score ≥ 4 during 3-day baseline period on the WORST pain scale of the BPI - Pain must correspond to areas of bone metastases, not to areas of visceral metastases e.g. liver metastases. - Minimum 3 weeks period after the last bisphosphonate treatment - No change in systemic anti-neoplastic therapy for at least 4 weeks prior to baseline period - Patients must be on a stable dose of, at least, a weak Opioid analgesic over the 3-day baseline period (maximum 10% variation is allowed) - ECOG Performance score of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease) - Adequate renal function: creatinine clearance ≥ 50ml/min (Cockroft formula) and serum creatinine ≤2.0mg/dl (168 µmol/L) - Normal serum calcium
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E.4 | Principal exclusion criteria |
- Patients with an uncontrolled infection - Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate - Patients with WBC count ≤ 1800/mm³ and/or platelet count ≤ 75000/ mm³ - Patients with known hypersensitivity to any of the components of ibandronic acid - Patients who are pregnant or lactating - Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results. - Radiotherapy to bone within the 28 days prior inclusion or during the trial duration - Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing (an investigational treatment is defined as one for which there is currently no regulatory-authority approved indication).
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E.5 End points |
E.5.1 | Primary end point(s) |
The main efficacy endpoint is bone response. In this trial, pain response is defined as > 25% decrease in mean pain score of WORST PAIN over a 7-day period compared to the mean pain score of WORST PAIN over a 3-day baseline period as determined by the WORST PAIN scale of BPI (Brief Pain Inventory) with a maximum of 10% increase in mean Opioid analgesic consumption over the same 7-day period compared to mean Opioid analgesic consumption over the 3-day baseline period. The WORST pain score is defined as the bone pain which occurs on movement, during night or spontaneously for unknown reasons.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |