Study of MK8669 in Patients With Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00694083

Purpose

A clinical study evaluates the safety, tolerability, and pharmacokinetics of MK8669 in patients with locally advanced or metastatic solid tumors.

Condition	Intervention	Phase
Neoplasm	Drug: MK8669	Phase I

MedlinePlus related topics: Cancer

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of MK8669 in Patients With Metastatic or Locally Advanced 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:	12
Study Start Date:	August 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Study medication	Drug: MK8669 MK8669 (20 or 40 mg) Oral, QD x5 (five consecutive days followed by two days holiday)for 4 consecutive weeks.

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
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
Any CNS Metastasis Which Has Symptom Or Requires Treatment
Any Primary Central Nervous System Tumor
Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694083

Locations

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_011, MK8669-003
Study First Received:	May 29, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00694083
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009