Advanced Cancer RelapsedPhase 1NCT00632931

A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)

A Phase 1 study testing vorinostat in people with Advanced Cancer Relapsed and Advanced Cancer Refractory, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer Relapsed, Advanced Cancer Refractory
What is being tested?: vorinostat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: No sites listed yet
Study dates: Jul 2007to Apr 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
Patient has life expectancy of greater than 3 months
Patient is able to swallow capsules

Who cannot join

Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
Patient has active CNS metastases and/or carcinomatous meningitis
Patient has primary central nervous system tumor
Patient has a history of drug or alcohol abuse
Patient has Hepatitis B or C
Patient is HIV positive
Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug

About this study

Official title: A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Read the detailed description

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Conditions: Advanced Cancer Relapsed, Advanced Cancer Refractory
Being tested: vorinostat, Comparator: placebo (unspecified)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vorinostatDrug
Also called MK0683, Zolinza®
A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.
Comparator: placebo (unspecified)Drug
A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

Study groups in NCT00632931
Study group	Role	What they receive
A	Experimental	Arm A: Drug/Placebo Receives: Drug: vorinostat; Drug: Comparator: placebo (unspecified)
B	Experimental	Arm B: Placebo/Drug Receives: Drug: vorinostat; Drug: Comparator: placebo (unspecified)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in QTcF at 0.5 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 0.5 hours
Change From Baseline in QTcF at 1 Hour
Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 1 hour
Change From Baseline in QTcF at 2 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 2 hours
Change From Baseline in QTcF at 3 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 3 hours
Change From Baseline in QTcF at 4 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.
Measured: Baseline and 4 hours
Change From Baseline in QTcF at 8 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 8 hours
Change From Baseline in QTcF at 12 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 12 hours
Change From Baseline in QTcF at 24 Hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Measured: Baseline and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Apr 2009

First posted11 Mar 2008 (estimated)
Study startJul 2007
Primary completionMay 2008
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Cancer RelapsedStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00632931
Sponsor's protocol ID: 0683-070
Other IDs: MK0683-070, 2008_515
Status last verified: Jul 2015
First submitted: 29 Feb 2008
Last updated: 30 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M. A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3.
PubMed 19887475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT00632931
Acronym / sponsor ID: 0683-070
Conditions: Advanced Cancer Relapsed, Advanced Cancer Refractory
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: May 2008 (actual)
Study completion: Apr 2009 (actual)
First posted: 11 Mar 2008 (estimated)
Results: Posted 15 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Detailed description

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: vorinostat, Drug: Comparator: placebo (unspecified)Arm A: Drug/Placebo
B	Experimental	Drug: vorinostat, Drug: Comparator: placebo (unspecified)Arm B: Placebo/Drug

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
Patient has life expectancy of greater than 3 months
Patient is able to swallow capsules

Key exclusion criteria (8 listed)

Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
Patient has active CNS metastases and/or carcinomatous meningitis
Patient has primary central nervous system tumor
Patient has a history of drug or alcohol abuse

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vorinostatAlso: MK0683, Zolinza®A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.	Drug	A, B
Comparator: placebo (unspecified)A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).	Drug	A, B

Primary outcome

Change From Baseline in QTcF at 0.5 Hours
Time frame: Baseline and 0.5 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 1 Hour
Time frame: Baseline and 1 hour
Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 2 Hours
Time frame: Baseline and 2 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 3 Hours
Time frame: Baseline and 3 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 4 Hours
Time frame: Baseline and 4 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.
Change From Baseline in QTcF at 8 Hours
Time frame: Baseline and 8 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 12 Hours
Time frame: Baseline and 12 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 24 Hours
Time frame: Baseline and 24 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.

Results and safety

Results posted to the registry on 15 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vorinostat Then Placebo: Part 1	13	11
Placebo Then Vorinostat: Part 1	12	12
All Participants: Part 2	0	0

Primary outcome: Change From Baseline in QTcF at 0.5 Hours

Time frame: Baseline and 0.5 hours. Mean (95% Confidence Interval). Unit: milliseconds

Measure	Vorinostat n = 23	Placebo n = 22
Value	1.78 (-1.53 to 5.09)	-1.22 (-4.53 to 2.08)

Vorinostat vs Placebo: Mean Difference (Final Values): 3.00 (90% CI -0.28 to 6.28)

Population analysed: All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)

Primary outcome: Change From Baseline in QTcF at 1 Hour

Time frame: Baseline and 1 hour. Mean (95% Confidence Interval). Unit: milliseconds

Measure	Vorinostat n = 23	Placebo n = 22
Value	0.22 (-3.09 to 3.52)	-1.23 (-4.54 to 2.08)

Vorinostat vs Placebo: Mean Difference (Final Values): 1.45 (90% CI -1.38 to 4.72)

Primary outcome: Change From Baseline in QTcF at 2 Hours

Time frame: Baseline and 2 hours. Mean (95% Confidence Interval). Unit: milliseconds

Measure	Vorinostat n = 23	Placebo n = 23
Value	1.09 (-2.22 to 4.40)	-1.98 (-5.23 to 1.28)

Vorinostat vs Placebo: Mean Difference (Final Values): 3.07 (90% CI -0.17 to 6.31)

Primary outcome: Change From Baseline in QTcF at 3 Hours

Time frame: Baseline and 3 hours. Mean (95% Confidence Interval). Unit: milliseconds

Measure	Vorinostat n = 23	Placebo n = 23
Value	1.32 (-1.99 to 4.63)	-1.52 (-4.77 to 1.73)

Vorinostat vs Placebo: Mean Difference (Final Values): 2.84 (90% CI -0.40 to 6.08)

Adverse events

Time frame: Reported adverse experiences are those from the time patients began study treatment until the patient discontinued. The average AE reporting timeframe is 78 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	11 of 25 (44%)	24 of 25 (96%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19887475Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M. A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing vorinostat in people with Advanced Cancer Relapsed and Advanced Cancer Refractory, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QTcF at 0.5 Hours (time frame: Baseline and 0.5 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00632931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.