NCT00290550

Brief Summary

This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

February 9, 2006

Last Update Submit

July 24, 2015

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced Non-Small Cell Lung CancerNSCLC

Outcome Measures

Primary Outcomes (1)

  • Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle.

    5 Days

Secondary Outcomes (1)

  • Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity.

    5 Days

Study Arms (1)

1

OTHER

MK-0457

Drug: MK0457

Interventions

MK0457DRUG

IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting)

You may not qualify if:

  • Patients who have had treatment with any investigational therapy within the past 30 days are not eligible.
  • Patients who have had a disease or medical condition that is not controlled will not be eligible.
  • Patients who are pregnant or breastfeeding are not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tozasertib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 13, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 27, 2015

Record last verified: 2015-07