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This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).
Patients selected by investigator according to clinical routine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated Liposomal Doxorubicin | Subjects with metastatic breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Liposomal Doxorubicin | Drug | Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infusion Reactions (IR) | Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia. | Day 1 up to Week 24 |
| Percent of Participants Taking Premedication for Prevention of IR | Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers. | Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin |
| Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR | Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria. | Cycles 1 & 3 (Week 4 & Week 12) |
| Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) | PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin. | Up to 24 weeks |
| Number of Times Premedications Were Given for Prevention of PPE | Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications. | Day 1 up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response (CR) or Partial Response (PR) | CR and PR were documented according to the clinical standards of each site. | Day 1 up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic breast cancer
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Liposomal Doxorubicin | Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Liposomal Doxorubicin | Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was calculated for the intent-to-treat (ITT) population only (those who received at least one dose of study medication). |
| 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 With Infusion Reactions (IR) | Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia. | Safety population (those who received at least one dose of study medication) | Posted | Number | Participants | Day 1 up to Week 24 |
|
|
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The safety data were from the safety population (those who received at least one dose of study medication).
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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 | Pegylated Liposomal Doxorubicin | Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Cllinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
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| Toxicity |
|
| Withdrawal by Subject |
|
| Death |
|
| Other |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender information was available only for the ITT population. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Complete Response (CR) or Partial Response (PR) | CR and PR were documented according to the clinical standards of each site. | Intent-to-treat (those who received at least one dose of study medication) | Posted | Number | Participants | Day 1 up to 24 weeks |
|
|
|
| Primary | Percent of Participants Taking Premedication for Prevention of IR | Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers. | Safety population (those who received at least one dose of study medication) | Posted | Number | Percent of participants | Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin |
|
|
|
| Primary | Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR | Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria. | Safety population (those who received at least one dose of study medication) | Posted | Number | Participants | Cycles 1 & 3 (Week 4 & Week 12) |
|
|
|
| Primary | Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) | PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin. | Safety population (those who received at least one dose of study medication) | Posted | Number | Occurrences | Up to 24 weeks |
|
|
|
| Primary | Number of Times Premedications Were Given for Prevention of PPE | Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications. | Safety population (those who received at least one dose of study medication) | Posted | Number | Number of times premedication was given | Day 1 up to 24 weeks |
|
|
|
| 5 |
| 160 |
| 9 |
| 160 |
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Histamine-2 receptor blockers |
|
| Title |
|---|
| Measurements |
|---|
|