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Study of MK0646 in Patients With Solid Tumors (0646-009)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 29, 2008
Last updated: February 4, 2015
Last verified: February 2015
A clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of MK0646 in patients with relapsed or refractory locally advanced or metastatic solid tumors using a once weekly and an every other week dose infusion regimen.

Condition Intervention Phase
Drug: MK0646
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MK0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Any clinical or laboratory adverse experience. [ Time Frame: Duration of Treatment ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Duration of Treatment ]

Enrollment: 18
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK0646
    MK0646 (5 or 10 mg/kg) IV infusion once weekly for 4 consecutive weeks

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically- Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Has Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Dose Not Exist
  • Tumors Associated With Igf-1r Expression In The Literature (E.G. Prostate, Pancreatic, Colon, Lung And Breast)
  • Ecog Performance Status 0 or 1
  • Adequate Organ Function

Exclusion Criteria:

  • Patient Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration
  • Patients Is Concurrently Using Growth Hormone (Gh), Or Growth Hormone Inhibitor
  • Any Active CNS Metastases And/Or Carcinomatous Meningitis
  • Any Primary Central Nervous System Tumor - Any Symptomatic Ascites Or Plural Effusion
  • A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Patient'S Participation, Or Pose An Additional Risk To The Patient
  • Pregnant Or Breast-Feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00694356

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00694356     History of Changes
Other Study ID Numbers: 0646-009
Study First Received: May 29, 2008
Last Updated: February 4, 2015

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017