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The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caelyx | Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it. | Participants will do a single visit, but cases will be collected during a period of 12 months. |
| Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE. | Participants will do a single visit, but cases will be collected during a period of 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caelyx | Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caelyx | Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it. | Posted | Number | Participants | Participants will do a single visit, but cases will be collected during a period of 12 months. |
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| Primary | Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE. | Posted | Number | Participants | Participants will do a single visit, but cases will be collected during a period of 12 months. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caelyx | Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment. | 3 | 154 | 122 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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Study data may be used in general publications or at conferences. Authorship will be attributed to those responsible for preparing the report and/or those who had a relevant part in designing the study. Whenever publication rules allow, all investigators will be listed individually.
Investigators may publish their data individually. In this case investigators will notify the study sponsor, including the communication/manuscript to be published, at least 30 days before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
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| Topical Dimethyl Sulfoxide |
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| Intravenous Dexamethasone |
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| Prostaglandins |
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| Avoid Excessive Heat/Water |
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| Keep Skin Hydrated |
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| Avoid Sweating and Physical Activity |
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| Avoid Tight-Fitting Clothing |
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| Local Cooling of Hands and Feet |
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