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This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aldesleukin | Experimental | All participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy | From Cycle 1, Day 1 to Cycle 2, Day 15 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Kenneth Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| University of Colorado Cancer Center |
A total of 26 participants were enrolled in the study. The study consisted of two cycles of aldesleukin, each cycle consisted of a 5-day period and a 9-day rest period between cycles.
Participants took part at 4 investigative sites in the United States from 03-September-2008 to 28-March-2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | mRCC Group | Participants with metastatic renal cell carcinoma (mRCC) were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
| FG001 | Metastatic Melanoma Group | Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety set consisted of all participants who received at least one dose of aldesleukin and had at least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | mRCC Group | Participants with mRCC were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy | The Pharmacokinetic Analysis (PK) set consisted of all participants in the safety set who completed two cycles of aldesleukin therapy and had evaluable post-baseline blood samples on Cycle 1, Day 1 and Cycle 2, Day 15. The Safety set consists of all participants who received at least one dose of aldesleukin and had at least one post-baseline safety assessment. | Posted | Mean | Standard Deviation | hour times picograms per mL(h × pg/mL) | From Cycle 1, Day 1 to Cycle 2, Day 15 |
|
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days.
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
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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 | mRCC | mRCC | 0 |
| 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 | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 18627788300 | Novartis.email@novartis.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Disease Progression |
|
| Metastatic Melanoma Group |
Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Metastatic Melanoma Group | Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. |
|
|
| 7 |
| 3 |
| 7 |
| 0 |
| 7 |
| EG001 | Metastatic Melanoma | Metastatic Melanoma | 0 | 19 | 4 | 19 | 0 | 19 |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |