Study of MK0646 in Patients With Solid Tumors - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 29, 2008

Last Updated Date

May 7, 2009

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00694356 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Pharmacokinetics [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study of MK0646 in Patients With Solid Tumors

Official Title ^†

A Phase I Study of MK0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Neoplasm

Intervention ^†

Drug: MK0646

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00694356

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0646-009

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.