Study of MK0646 in Patients With Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00694356

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

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 ]

Estimated Enrollment:	18
Study Start Date:	August 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Locations

Japan, Chiyodaku
Merck Ltd., Japan	Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi 81-3-6272-1547

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_012, MK0646-009
Study First Received:	May 29, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00694356
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009