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
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 April 22, 2014