A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00104351
First received: February 25, 2005
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

The purpose of this trial is to study an investigational drug in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.


Condition Intervention Phase
Cancer
Drug: VX-680 (an Aurora Kinase Inhibitor)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability of a 24 hour CIV infusion every 21 days [ Time Frame: Trial Duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate radiologic response and pharmacodynamic biomarker response to treatment [ Time Frame: Trial Duration ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
MK0457
Drug: VX-680 (an Aurora Kinase Inhibitor)
24 hr CIV infusion at rising dose levels of 2, 4, 8, 16, 32 and 64 mg/m2/hour; 5-day continuous infusion every 21 days.
Other Name: MK0457

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

Exclusion Criteria:

  • Patients who have had treatment with any investigational therapy within the past 30 days.
  • Patients who have certain types of blood cancers such as leukemia or lymphoma.
  • Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.
  • Patient is pregnant or nursing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104351

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00104351     History of Changes
Other Study ID Numbers: 2005_005, MK0457-002
Study First Received: February 25, 2005
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 18, 2014