Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02532868
Other study ID # 0457-002
Secondary ID 2005_005
Status Terminated
Phase Phase 1
First received July 18, 2014
Last updated August 25, 2015
Start date May 2005
Est. completion date January 2008

Study information

Verified date August 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MK-0457


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) Up to 21 days Yes
Secondary Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans Predose, and at end of Cycles 2 and 6 (up to approximately 4 months) No
Secondary Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST) Pre-dose through post-study visit (up to 3 years) No
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients