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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00424775
First received: January 19, 2007
Last updated: March 21, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

  • Maximum Concentration (Cmax) at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424775

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00424775     History of Changes
Other Study ID Numbers: 2007_001, MK0683-066
Study First Received: January 19, 2007
Results First Received: April 3, 2009
Last Updated: March 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on April 17, 2014