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

May 29, 2008
October 19, 2012
August 2008
March 2009   (final data collection date for primary outcome measure)
Any clinical or laboratory adverse experience. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00694356 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of MK0646 in Patients With Solid Tumors (0646-009)(COMPLETED)
A Phase I Study of MK0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm
Drug: MK0646
MK0646 (5 or 10 mg/kg) IV infusion once weekly for 4 consecutive weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00694356
2008_012, MK0646-009
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP