A Continuation Clinical Trial of Oral Vorinostat (MK-0683... | NCT00907738 | Trialant
NCT00907738
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
May 21, 2015Estimated
Enrollment
27Actual
Phase
Phase 2
Conditions
Advanced Cancer
Interventions
vorinostat
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00907738
Obsolete or Duplicate NCT IDs
NCT00588055
Organization Study
0683-007
Secondary IDs
ID
Type
Description
Link
2009_595
Brief Title
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
Official Title
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2005
Primary Completion Date
Jun 2010Actual
Completion Date
Jun 2010Actual
First Submitted Date
May 21, 2009
First Submission Date that Met QC Criteria
May 21, 2009
First Posted Date
May 25, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 14, 2011
Results First Submitted that Met QC Criteria
Jun 14, 2011
Results First Posted Date
Jul 14, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 5, 2015
Last Update Posted Date
May 21, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
27Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Vorinostat
Experimental
Drug: vorinostat
Interventions
Name
Type
Description
Arm Group Labels
Other Names
vorinostat
Drug
All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.
Vorinostat
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent of Participants With a Serious Drug-related Adverse Event (AE)
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.
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)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
Patient did not withdraw from the base protocol
Patient agrees to practice effective birth control during the study
Exclusion Criteria:
Patient is receiving other standard and/or investigational anticancer therapy
Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. doi: 10.3816/CLM.2009.n.082.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Base Protocol 001
Vorinostat 400 mg daily (QD)
FG001
Base Protocol 006
vorinostat 200 mg twice daily (BID)
FG002
Base Protocol 008
vorinostat 400 mg QD
FG003
Base Protocol 012
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
FG004
Base Protocol 013
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00013 subjects
FG0011 subjects
FG0027 subjects
FG0034 subjects
FG0042 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00013 subjects
FG0011 subjects
FG0027 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Base Protocol 001
Vorinostat 400 mg daily (QD)
BG001
Base Protocol 006
vorinostat 200 mg twice daily (BID)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
All participants were at least 18 years of age.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent of Participants With a Serious Drug-related Adverse Event (AE)
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.
Posted
Number
percent of participants
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)
ID
Title
Description
OG000
Base Protocol 001
Vorinostat 400 mg daily (QD)
OG001
Base Protocol 006
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chest pain
General disorders
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
More Info Module
Limitations and Caveats
Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
D000077337
Vorinostat
Ancestor Terms
ID
Term
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Aniline Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MK-0683
0 subjects
2 subjects
0 subjects
FG0040 subjects
not specified or withdrew consent
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Disease progression
FG0008 subjects
FG0011 subjects
FG0026 subjects
FG0034 subjects
FG0042 subjects
BG002
Base Protocol 008
vorinostat 400 mg QD
BG003
Base Protocol 012
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
BG004
Base Protocol 013
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
BG005
Total
Total of all reporting groups
13
BG0011
BG0027
BG0034
BG0042
BG00527
Number
Participants
Title
Denominators
Categories
Title
Measurements
BG00013
BG0011
BG0027
BG0034
BG0042
BG00527
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0010
BG0024
BG0031
BG0042
BG00515
Male
BG0005
BG0011
BG0023
BG0033
BG004
vorinostat 200 mg twice daily (BID)
OG002
Base Protocol 008
vorinostat 400 mg QD
OG003
Base Protocol 012
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
OG004
Base Protocol 013
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
Units
Counts
Participants
OG00013
OG0011
OG0027
OG0034
OG0042
Title
Denominators
Categories
Title
Measurements
OG0007.7
OG0010
OG0020
OG0030
OG0040
4
13
6
13
EG001
Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])
1
1
0
1
EG002
Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])
1
7
2
7
EG003
Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)
0
1
0
1
EG004
Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)
1
1
1
1
EG005
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)
0
1
0
1
EG006
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)
0
1
0
1
EG007
Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)
0
1
1
1
EG008
Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
0
1
1
1
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Cholangitis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Cholecystitis
Hepatobiliary disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Pneumonia
Infections and infestations
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0004 events3 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
Abdominal pain lower
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected1 at risk
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Lobar pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Blood lactate dehydrogenase increased
Investigations
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Anorexia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Haematuria
Renal and urinary disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Skin lesion
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.