MelanomaPhase 1NCT00457418
High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)
A Phase 1 study testing PEG-Intron in people with Melanoma, run by Merck Sharp & Dohme LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PEG-Intron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2007to 11 Jul 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects at least 18 years of age, of either sex, and of any race.
- Cytologically or histologically-confirmed melanoma, arising from a cutaneous or unknown site of origin, at Stages IIB, IIC, IIIA, IIIB, IIIC according to the American Joint Committee on Cancer (AJCC) 2001 guidelines.
- Adequate hepatic, renal and bone marrow function within 4 weeks prior to initiation of study treatment.
- Subjects presenting with synchronous primary and regional melanoma must have had adequate surgical margins surrounding the primary lesion.
- Full lymphadenectomy must be performed within 90 days prior to initiation of study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Give informed consent according to International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and national/local policy.
- Be able to adhere to dose and visit schedules.
- Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study or be surgically sterilized.
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening.
Who cannot join
- Female subjects who are pregnant, intend to become pregnant, or are breastfeeding.
- Previous treatment with interferon alpha, chemotherapy or immunotherapy for melanoma.
- Ocular melanoma, or melanoma of the mucous membranes.
- Evidence of distant or non-regional lymph node metastases.
- In-transit melanoma, even if the lesion has been resected.
- Disease that cannot be completely surgically resected.
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- Lack of recovery from recent surgery.
- Prior malignancy within the past 5 years, except surgically cured squamous cell carcinoma of the skin, successfully resected early stage cutaneous melanoma, or cervical carcinoma in situ.
- Severe cardiovascular disease.
- Thyroid dysfunction not responsive to therapy.
- Uncontrolled diabetes mellitus (in the opinion of the investigator).
- Active autoimmune disease.
- Active and/or uncontrolled infection.
- History of seropositivity for human immunodeficiency virus (HIV).
- Pre-existing psychiatric condition.
- Clinical diagnosis of substance abuse of one or more of the following drugs within the following timeframes (excluding time spent in detoxification, hospitalization or incarceration):
- Alcohol, intravenous drug use, inhalational, psychotropics, narcotics, cocaine, prescription or over-the-counter drugs: within 1 year of the Screening visit.
- Methadone, buprenorphine hydrochloride (HCl), and/or butorphanol tartrate: within 1 year of Screening visit, unless subject has drug screen negative for other (non-narcotic) drugs documented in the past year and repeated negative within 2 months of Screening visit.
- Multi-drug abuse (2 or more substances in 16a and 16b): within 3 years of Screening visit.
- Marijuana:
- If historic use is deemed excessive by the principal investigator (or medically qualified individual), or is interfering with the subject's life, then the subject is not eligible and should not be screened.
- If marijuana use is not deemed excessive by principal investigator and does not interfere with life, subject must discontinue any current use of marijuana prior to entry into study.
- Medical condition requiring chronic systemic corticosteroids.
- Known allergy to the drug substance or any of the excipients in the PEG-Intron formulation.
- Any situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Use of any investigational drugs within 30 days of study entry.
- Participation in other clinical studies of investigational treatments.
About this study
Official title: A Pharmacokinetic Study of PEG-Intron, Administered Weekly in Subjects With High-Risk Melanoma
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.
- Conditions
- Melanoma
- Being tested
- PEG-Intron
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IntronDrug
Also called SCH 054031, peginterferon alfa-2b
| Study group | Role | What they receive |
|---|---|---|
| PEG-Intron | Experimental | 6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance) Receives: Drug: PEG-Intron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of PEG-Intron at 12 Weeks
AUC was defined as the actual body exposure to drug after administration of a dose of the drug.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks
Cmax was defined as observed maximum plasma concentration.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks
Cavg was defined as average plasma concentration.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks
Cmin was defined as observed minimum plasma concentration.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks
Tmax was defined as time of maximum plasma concentration.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks
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.
Measured: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Secondary outcomes (1)
Number of Participants Who Experienced an Adverse Event (AE)
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.
Measured: Entire study duration (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study start20 Feb 2007
- Primary completion27 May 2008
- Study completion11 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457418
- Sponsor's protocol ID
- P04831
- Status last verified
- May 2017
- First submitted
- 5 Apr 2007
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Daud AI, Xu C, Hwu WJ, Urbas P, Andrews S, Papadopoulos NE, Floren LC, Yver A, Deconti RC, Sondak VK. Pharmacokinetic/pharmacodynamic analysis of adjuvant pegylated interferon alpha-2b in patients with resected high-risk melanoma. Cancer Chemother Pharmacol. 2011 Mar;67(3):657-66. doi: 10.1007/s00280-010-1326-9. Epub 2010 May 28.
PubMed 20509027
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of PEG-Intron, Administered Weekly in Subjects With High-Risk Melanoma
- ClinicalTrials.gov ID
- NCT00457418
- Acronym / sponsor ID
- P04831
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2007 (actual)
- Primary completion
- 27 May 2008 (actual)
- Study completion
- 11 Jul 2012 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Posted 31 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-Intron | Experimental | Drug: PEG-Intron6 ug/kg/week, SC (first 8 weeks) 3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects at least 18 years of age, of either sex, and of any race.
- Cytologically or histologically-confirmed melanoma, arising from a cutaneous or unknown site of origin, at Stages IIB, IIC, IIIA, IIIB, IIIC according to the American Joint Committee on Cancer (AJCC) 2001 guidelines.
- Adequate hepatic, renal and bone marrow function within 4 weeks prior to initiation of study treatment.
- Subjects presenting with synchronous primary and regional melanoma must have had adequate surgical margins surrounding the primary lesion.
- Full lymphadenectomy must be performed within 90 days prior to initiation of study treatment.
Key exclusion criteria (27 listed)
- Female subjects who are pregnant, intend to become pregnant, or are breastfeeding.
- Previous treatment with interferon alpha, chemotherapy or immunotherapy for melanoma.
- Ocular melanoma, or melanoma of the mucous membranes.
- Evidence of distant or non-regional lymph node metastases.
- In-transit melanoma, even if the lesion has been resected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-IntronAlso: SCH 054031, peginterferon alfa-2b | Drug | PEG-Intron |
Primary outcome
Area Under the Curve (AUC) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
AUC was defined as the actual body exposure to drug after administration of a dose of the drug.
Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Cmax was defined as observed maximum plasma concentration.
Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Cavg was defined as average plasma concentration.
Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Cmin was defined as observed minimum plasma concentration.
Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
Tmax was defined as time of maximum plasma concentration.
Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks
Time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks
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.
1 secondary outcome
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Entire study duration (up to 5 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20509027Daud AI, Xu C, Hwu WJ, Urbas P, Andrews S, Papadopoulos NE, Floren LC, Yver A, Deconti RC, Sondak VK. Pharmacokinetic/pharmacodynamic analysis of adjuvant pegylated interferon alpha-2b in patients with resected high-risk melanoma. Cancer Chemother Pharmacol. 2011 Mar;67(3):657-66. doi: 10.1007/s00280-010-1326-9. Epub 2010 May 28.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEG-Intron in people with Melanoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of PEG-Intron at 12 Weeks (time frame: Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.