E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of bone metastases in elderly patients with solid tumors |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027484 |
E.1.2 | Term | Metastatic 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 |
Bone pain response.
In this study, pain response is defined as a:
25% decrease in mean pain score over a 7-day period compared to mean pain score at Screening, with no more than a 15% increase in mean analgesic consumption over the same 7-day period compared to mean Screening analgesic consumption that persists for at least 6 weeks, as determined by the モWORST PAINヤ scale of the Brief Pain Inventory (BPI). |
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E.2.2 | Secondary objectives of the trial |
- Pain response as defined above determined by the モAVERAGE PAINヤ scale of the BPI
- Duration of pain response based on the WORST PAIN and AVERAGE PAIN scales of the BPI where duration is defined as the period of time from the first evidence of response (assuming confirmation 6 weeks later) to that time when the mean pain score over a 7-day period on the WORST PAIN scale increases by 25% over Screening for 2 consecutive weeks; when the mean opioid consumption increases by 50% over Screening for 2 consecutive weeks; or when a patient receives radiotherapy for bone pain.
- Time to pain response based on the WORST PAIN and AVERAGE PAIN scales of the BPI
- Interference scales of the BPI
- Analgesic consumption, expressed as opioid equivalents
- Opioid side-effects
- WHO Performance Score
- Quality of life measured by the EORTC QLQ-C30 scale
- A Patient Global Assessment
- Toxicity, safety and tolerance of i.v. and oral ibandronic acid |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histological or cytological evidence of solid tumor (breast cancer, hormone-refractory prostate cancer, lung cancer and all others). Patients with prostate cancer must have progressive neoplastic disease despite at least 3 months of hormonal therapy, defined as a rise in PSA on 3 separate occasions at least 2 weeks apart or clear evidence of new bone metastases
Presence of bone metastases documented on bone scan and bone x-ray or CT scan or MRI
Mean pain score of >5 over a 7-day Screening period on the WORST PAIN scale of the BPI
Bone pain must correspond to areas of metastases on bone scintigram and bone x-ray or CT scan or MRI; patients whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to insure that each patient's pain is primarily due to bone metastatic disease.
Age >70 years
The use of at least a weak opioid based on the WHO Analgesic ladder
No change in systemic anti-neoplastic therapy for at least 6 weeks prior to Screening period
WHO Performance Score of 0 ヨ 2
Adequate renal function as evidenced by serum creatinine <2.0 mg/dL (168 ᄉmol/L)
Normal serum calcium level
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial |
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E.4 | Principal exclusion criteria |
Patients with an active infection or with a fever >38.50 C within 3 days of the first scheduled day of dosing
Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process)
Patients with known symptomatic CNS or meningeal metastases
Patients who have received a bisphosphonate within 3 weeks of the start of the Screening period; however, use of bisphosphonates prior to this period is permitted
Patients with known hypersensitivity to any of the components of ibandronic
Patient requiring a dentistry intervention which planned duration is more than one month (Patient requiring a dentistry intervention which planned duration is less than one month can be enrolled only after dentistry intervention)
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication. モInvestigational therapyヤ does not refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor.
Radiotherapy to bone within 4 weeks of the Screening period
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 interfere with the interpretation of the results. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain response defined as a 25% decrease in mean pain score over a 7-day period compared to mean pain score at Screening, with no more than a 15% increase in mean analgesic consumption over the same 7-day period compared to mean Screening analgesic consumption that persists for at least 6 weeks, as determined by the モWORST PAINヤ scale of the Brief Pain Inventory (BPI). |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
different pharmaceutical form and route of administration |
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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 | 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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |