High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)

NCT00457418 | Completed Phase 1 Results

• 1 other identifier: P04831
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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)

  Entire study duration (up to 5 years)

Study Arms (1)

PEG-Intron

EXPERIMENTAL

6 ug/kg/week, SC (first 8 weeks) 3 ug/kg/week, SC (252 weeks \[weeks 9-260\], maintenance)

Drug: PEG-Intron

Interventions

PEG-Intron DRUG

Also known as: SCH 054031, peginterferon alfa-2b

PEG-Intron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 20509027 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President,Global CLinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: February 20, 2007
• Primary Completion: May 27, 2008
• Study Completion: July 11, 2012
• Last Updated: June 7, 2017
• Results First Posted: July 31, 2013

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share