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The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.
Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.
The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women with advanced ovarian cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caelyx (Pegylated Lyposomal Doxorubicin) | Drug | Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention. | The observational program was conducted over a period of 2 years |
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Inclusion Criteria:
Women with advanced ovarian cancer with:
Exclusion Criteria:
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Women with advanced ovarian cancer with:
previous platin/taxane therapy and
documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19955744 | Result | Steppan I, Reimer D, Sevelda U, Ulmer H, Marth C, Zeimet AG. Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity. Chemotherapy. 2009;55(6):391-8. doi: 10.1159/000262452. Epub 2009 Nov 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Lyposomal Doxorubicin | 50 mg/m2 every 4 weeks for 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Lyposomal Doxorubicin | 50 mg/m2 every 4 weeks for 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 | Mean age was calculated for the Intent-to-Treat (ITT) population of 214. |
| 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 | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention. | Intent-to-treat (ITT) (N=214). This is also the Safety population. | Posted | Number | Events | The observational program was conducted over a period of 2 years |
|
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Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
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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 Lyposomal Doxorubicin | 50 mg/m2 every 4 weeks for 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
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| Death |
|
| Reason for discontinuation not specified |
|
| No documentation available |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 14 |
| 214 |
| 0 |
| 214 |
| Ascites | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| General physical health deterioraton | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
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| 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 |