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High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)
Phase 1 trial testing PEG-Intron in Melanoma in 32 participants. Completed in 11 July 2012.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 20 February 2007 |
| Primary completion | 27 May 2008 |
| Estimated completion | 11 July 2012 |
Merck Sharp & Dohme LLC — full company profile →
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
AUC was defined as the actual body exposure to drug after administration of a dose of the drug.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 235000 | 207592 – 251430 |
Cmax was defined as observed maximum plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 2620 | 2173 – 2829 |
Cavg was defined as average plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 1400 | 1236 – 1497 |
Cmin was defined as observed minimum plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 626 | 498 – 678 |
Tmax was defined as time of maximum plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 24.00 | 24.00 – 48.00 |
CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 0.0129 | ± 0.00284 |
An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product.
| Group | Value | 95% CI |
|---|---|---|
| PEG-Intron | 32 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | PEG-Intron |
|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | — |
| CARDIAC ARREST | Cardiac disorders | — |
| GLAUCOMA | Eye disorders | — |
| CHOLECYSTITIS | Hepatobiliary disorders | — |
| DRUG HYPERSENSITIVITY | Immune system disorders | — |
| APPENDICITIS PERFORATED | Infections and infestations | — |
| BRONCHITIS | Infections and infestations | — |
| SEPSIS | Infections and infestations | — |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | — |
| WRIST FRACTURE | Injury, poisoning and procedural complications | — |
| RENAL FAILURE | Renal and urinary disorders | — |
| URTICARIA | Skin and subcutaneous tissue disorders | — |
| Reaction | System | PEG-Intron |
|---|---|---|
| FATIGUE | General disorders | — |
| PYREXIA | General disorders | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — |
| CHILLS | General disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| HEADACHE | Nervous system disorders | — |
| DIARRHOEA | Gastrointestinal disorders | — |
| MYALGIA | Musculoskeletal and connective tissue disorders | — |
| INJECTION SITE REACTION | General disorders | — |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | — |
| DEPRESSION | Psychiatric disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| NEUTROPHIL COUNT DECREASED | Investigations | — |
| RASH | Skin and subcutaneous tissue disorders | — |
| INSOMNIA | Psychiatric disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| ANXIETY | Psychiatric disorders | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — |
| INFLUENZA LIKE ILLNESS | General disorders | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — |
| DIZZINESS | Nervous system disorders | — |
| SOMNOLENCE | Nervous system disorders | — |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| OEDEMA | General disorders | — |
| DEHYDRATION | Metabolism and nutrition disorders | — |
| MOOD ALTERED | Psychiatric disorders | — |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | — |
| LEUKOPENIA | Blood and lymphatic system disorders | — |
| HYPOTHYROIDISM | Endocrine disorders | — |
| DRY EYE | Eye disorders | — |
| DRY MOUTH | Gastrointestinal disorders | — |
| SINUSITIS | Infections and infestations | — |
Most-reported serious reactions: ATRIAL FIBRILLATION, CARDIAC ARREST, GLAUCOMA, CHOLECYSTITIS, DRUG HYPERSENSITIVITY, APPENDICITIS PERFORATED, BRONCHITIS, SEPSIS.
Data from ClinicalTrials.gov NCT00457418 adverse events section.
The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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