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A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00424775
First Posted: January 22, 2007
Last Update Posted: April 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.

Condition Intervention Phase
Neoplasms Drug: MK0683, vorinostat Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With a Dose Limited Toxicity at First Cycle [ Time Frame: 25 Days (first cycle) ]
    Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.


Secondary Outcome Measures:
  • Area Under the Curve (AUC(0-24 hr)) at Day 4 [ Time Frame: Day 4 ]
    Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.

  • Area Under the Curve (AUC(0-24 hr)) at Day 5 [ Time Frame: Day 5 ]
    Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.

  • Maximum Concentration (Cmax) at Day 4 [ Time Frame: Day 4 ]
    Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

  • Maximum Concentration (Cmax) at Day 5 [ Time Frame: Day 5 ]
    Maximum Concentration (Cmax) = the maximum plasma concentration of the drug


Enrollment: 3
Study Start Date: January 2007
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK0683, vorinostat
    vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
    Other Name: MK0683
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV
  • Patients with normal organ function and bone marrow function

Exclusion Criteria:

  • Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks
  • Any peripheral neuropathy above grade 2
  • Any ascites, pleural effusion or pericardiac effusion which requires treatment
  • Any uncontrolled concomitant illness
  • Pregnant or breast-feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424775


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00424775     History of Changes
Other Study ID Numbers: 0683-066
2007_001
First Submitted: January 19, 2007
First Posted: January 22, 2007
Results First Submitted: April 3, 2009
Results First Posted: June 1, 2009
Last Update Posted: April 20, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Non-Small Cell Lung Cancer (NSCLC)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Vorinostat
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors
Enzyme Inhibitors