Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00694356
First received: May 29, 2008
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Neoplasm
 Drug: MK0646
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Any clinical or laboratory adverse experience. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694356

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00694356     History of Changes
Other Study ID Numbers: 2008_012, MK0646-009
Study First Received: May 29, 2008
Last Updated: October 19, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013