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A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

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.
 
ClinicalTrials.gov Identifier: NCT00907738
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 14, 2011
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Cancer
Intervention Drug: vorinostat
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Base Protocol 001 Base Protocol 006 Base Protocol 008 Base Protocol 012 Base Protocol 013
Hide Arm/Group Description Vorinostat 400 mg daily (QD) vorinostat 200 mg twice daily (BID) vorinostat 400 mg QD 400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
Period Title: Overall Study
Started 13 1 7 4 2
Completed 0 0 0 0 0
Not Completed 13 1 7 4 2
Reason Not Completed
Adverse Event             2             0             1             0             0
not specified or withdrew consent             3             0             0             0             0
Disease progression             8             1             6             4             2
Arm/Group Title Base Protocol 001 Base Protocol 006 Base Protocol 008 Base Protocol 012 Base Protocol 013 Total
Hide Arm/Group Description Vorinostat 400 mg daily (QD) vorinostat 200 mg twice daily (BID) vorinostat 400 mg QD 400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week) Total of all reporting groups
Overall Number of Baseline Participants 13 1 7 4 2 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 1 participants 7 participants 4 participants 2 participants 27 participants
13 1 7 4 2 27
[1]
Measure Description: All participants were at least 18 years of age.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 1 participants 7 participants 4 participants 2 participants 27 participants
Female
8
  61.5%
0
   0.0%
4
  57.1%
1
  25.0%
2
 100.0%
15
  55.6%
Male
5
  38.5%
1
 100.0%
3
  42.9%
3
  75.0%
0
   0.0%
12
  44.4%
1.Primary Outcome
Title Percent of Participants With a Serious Drug-related Adverse Event (AE)
Hide Description

A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.

A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.

Time Frame From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Base Protocol 001 Base Protocol 006 Base Protocol 008 Base Protocol 012 Base Protocol 013
Hide Arm/Group Description:
Vorinostat 400 mg daily (QD)
vorinostat 200 mg twice daily (BID)
vorinostat 400 mg QD
400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
Overall Number of Participants Analyzed 13 1 7 4 2
Measure Type: Number
Unit of Measure: percent of participants
7.7 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description

The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1.

Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.

 
Arm/Group Title Base Protocol 001 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID]) Base Protocol 008 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21) Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21) Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21) Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID]) Base Protocol 008 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21) Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21) Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21) Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID]) Base Protocol 008 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21) Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21) Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21) Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/13 (30.77%)      1/1 (100.00%)      1/7 (14.29%)      0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)    
General disorders                   
Chest pain   0/13 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Hepatobiliary disorders                   
Cholangitis   0/13 (0.00%)  0 1/1 (100.00%)  1 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Cholecystitis   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                   
Pneumonia   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Investigations                   
Blood creatine phosphokinase increased   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Ovarian cancer   0/13 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Tongue neoplasm malignant stage unspecified   0/13 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Chronic obstructive pulmonary disease   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Rash   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID]) Base Protocol 008 (Vorinostat 400 mg Once Daily [QD]) Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21) Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21) Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21) Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21) Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/13 (46.15%)      0/1 (0.00%)      2/7 (28.57%)      0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      0/1 (0.00%)      1/1 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders                   
Thrombocytopenia   3/13 (23.08%)  4 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Gastrointestinal disorders                   
Abdominal pain lower   0/13 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Constipation   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Diarrhoea   2/13 (15.38%)  2 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Nausea   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders                   
Fatigue   0/13 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                   
Lobar pneumonia   0/13 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Investigations                   
Blood creatine phosphokinase increased   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Blood lactate dehydrogenase increased   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                   
Anorexia   0/13 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Muscle spasms   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders                   
Haematuria   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Rash   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Skin lesion   1/13 (7.69%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00907738    
Obsolete Identifiers: NCT00588055
Other Study ID Numbers: 0683-007
2009_595
First Submitted: May 21, 2009
First Posted: May 25, 2009
Results First Submitted: June 14, 2011
Results First Posted: July 14, 2011
Last Update Posted: May 21, 2015