E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
treatment of women with breat cancer and mbd |
|
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 | 10006187 |
E.1.2 | Term | Breast cancer |
|
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 |
In women with breast cancer and MBD:
2.1.1 Primary Objective:
1) To assess the effect of 4 weeks of treatment with MK-0822 50 mg once weekly
on u-NTx, a biochemical index of bone resorption, relative to baseline.
2) To assess the safety and tolerability of 4 weeks of treatment with MK-0822 50 mg
once weekly. |
|
E.2.2 | Secondary objectives of the trial |
2.1.3 Secondary Objectives:
1) To assess the effect of 4 weeks of treatment with MK-0822 50 mg weekly on
urinary deoxypyridinoline (u-DPD), another marker of bone resorption, on serum
1CTP, a biochemical index of collagen breakdown and cathepsin K activity, and
on serum Bone Specific Alkaline Phosphatase (BSAP), a marker of bone
formation.
2) To assess the pharmacokinetic profile of MK-0822 during 4 weeks of therapy.
2.2 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
2.2 SUBJECT/PATIENT INCLUSION CRITERIA
1) Patient has histologically- and/or cytologically-confirmed breast cancer.
2) Patient has documented skeletal metastases. Historical bone scans taken up to
12 months prior to study start are acceptable.
3) Patient is a woman >= 18 years of age on day of signing the informed consent.
4) Patient is not receiving chemotherapy OR if patient is receiving chemotherapy,
she is on a stable chemotherapy regimen for at least 1 month at the time of
screening (Visit 1).
5) Patient is not receiving hormonal therapy OR if patient is receiving hormonal
therapy, she is on a stable regimen for at least 3 months at the time of screening
(Visit 1). |
|
E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria are not eligible to participate in this study:
1) Patient is undergoing current oral bisphosphonate therapy OR has history of oral or
IV bisphosphonate use within 3 months of screening (Visit 1).
2) Patient has a presence of clinically apparent central nervous system (CNS)
metastases or carcinomatous meningitis. A patient with CNS metastases who has
completed a course of radiotherapy prior to screening (Visit 1), and is clinically
stable in the judgment of the investigator is eligible.
3) Patient has a primary CNS tumor.
4) Patient has presence of ascites or pleural effusion causing significant symptoms.
5) Patient is currently participating or has participated in a study with an investigational
compound or device within 30 days of signing the informed consent.
6) Patient has active and uncontrolled infection. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
If the average percent reduction of u-NTx from baseline at Week 4 in the MK-0822
group is greater than 60%, the lower bound of the 95% CI will be approximately >50%,
meeting the criterion for a substantial suppression of u-NTx; If the average percent
reduction of u-NTx from baseline at Week 4 is approximately 50%, the 95% CI includes
50% suppression. In this case, criterion for a substantial suppression may be achieved.
Other pharmacodynamic endpoints will be assessed and evaluated for supportive
evidence; If, on the other hand, the average percent reduction of u-NTx from baseline at
Week 4 is less than 40%, the upper bound of the 95% CI is approximately <50%. In this
case, criterion for a substantial suppression is NOT achieved at this MK-0822 dose.
Internal/external data will be explored and assessed to determine path forward. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| |
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 | 1 |
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 | 2 |