Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00423449
First received: January 17, 2007
Last updated: July 6, 2011
Last verified: July 2011

January 17, 2007
July 6, 2011
March 2007
April 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ] [ Designated as safety issue: Yes ]
    DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.
  • Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ] [ Designated as safety issue: Yes ]

    Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.

    The MTD was 400 mg for up to 10 days in 21-day cycles.

Determine the maximum tolerated dose (MTD) of vorinostat administered for 7 to 14 days in repeated 21-day cycles in combination with standard doses of gemcitabine plus either cisplatin or carboplatin in previously chemo naive patients w/ advanced NSCLC
Complete list of historical versions of study NCT00423449 on ClinicalTrials.gov Archive Site
  • Number of Participants With Clinical Adverse Experiences (Safety and Tolerability) [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ] [ Designated as safety issue: Yes ]

    An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.

    The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).

  • Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability) [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ] [ Designated as safety issue: Yes ]

    An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.

    The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).

To assess at MTD the pharmacokinetics of vorinostat, gemcitabine and either cisplatin or carboplatin when administered in combination
Not Provided
Not Provided
 
Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: vorinostat
    Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days
  • Drug: Gemcitabine
    Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle
  • Drug: Platinum-based agent
    Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.
Experimental: Vorinostat + Gemcitabine + Platinum-based agent
Interventions:
  • Drug: vorinostat
  • Drug: Gemcitabine
  • Drug: Platinum-based agent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment

Exclusion Criteria:

  • Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00423449
MK-0683-058, 2006_528
Not Provided
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP