TumorsPhase 1NCT00373490

A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)

A Phase 1 study testing Vorinostat in people with Tumors, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Tumors
What is being tested?: Vorinostat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: Jul 2006to Oct 2007
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy

Who cannot join

Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks
Any uncontrolled concomitant illness
Pregnant or breast-feeding
Serious drug or food allergy

About this study

Official title: MK0683 Phase1 Clinical Study - Solid Tumor -

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

Conditions: Tumors
Being tested: Vorinostat
Medical subject headings: Neoplasms

What participants receive

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

VorinostatDrug
Also called MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)
600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
VorinostatDrug
Also called MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Study groups in NCT00373490
Study group	Role	What they receive
Vorinostat 600 mg	Experimental	600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest. Receives: Drug: Vorinostat
Vorinostat 400 mg	Experimental	400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. Receives: Drug: Vorinostat

What is being measured

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

Number of Participants With a Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment
Measured: 21 Days (first cycle)

Secondary outcomes (6)

Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.
Measured: Day 1 (600 mg and 400 mg)
Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)
Measured: Day 3 (600 mg)
Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)
Measured: Day 21 (400 mg)
Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)
Measured: Day 1 (600 mg and 400 mg)
Maximum Concentration (Cmax) at Day 3 (600 mg)
Measured: Day 3 (600 mg)
Maximum Concentration (Cmax) at Day 21 (400 mg)
Measured: Day 21 (400 mg)

Timeline

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

Jul 2006Oct 2007

First posted8 Sep 2006 (estimated)
Study startJul 2006
Primary completionOct 2007
Study completionOct 2007

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 TumorsStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00373490
Sponsor's protocol ID: 0683-048
Other IDs: MK0683-048, 2006_030
Status last verified: Aug 2015
First submitted: 7 Sep 2006
Last updated: 27 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Doi T, Hamaguchi T, Shirao K, Chin K, Hatake K, Noguchi K, Otsuki T, Mehta A, Ohtsu A. Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial. Int J Clin Oncol. 2013 Feb;18(1):87-95. doi: 10.1007/s10147-011-0348-6. Epub 2012 Jan 11.
PubMed 22234637

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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All Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MK0683 Phase1 Clinical Study - Solid Tumor -
ClinicalTrials.gov ID: NCT00373490
Acronym / sponsor ID: 0683-048
Conditions: Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 8 Sep 2006 (estimated)
Results: Posted 20 May 2009

Clinical summary

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

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vorinostat 600 mg	Experimental	Drug: Vorinostat600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
Vorinostat 400 mg	Experimental	Drug: Vorinostat400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy

Key exclusion criteria (4 listed)

Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks
Any uncontrolled concomitant illness
Pregnant or breast-feeding
Serious drug or food allergy

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: MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.	Drug	Vorinostat 600 mg
VorinostatAlso: MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.	Drug	Vorinostat 400 mg

Primary outcome

Number of Participants With a Dose Limiting Toxicity (DLT)
Time frame: 21 Days (first cycle)
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment

6 secondary outcomes

Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)
Time frame: Day 1 (600 mg and 400 mg)
Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)
Time frame: Day 3 (600 mg)
Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)
Time frame: Day 21 (400 mg)
Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)
Time frame: Day 1 (600 mg and 400 mg)
Maximum Concentration (Cmax) at Day 3 (600 mg)
Time frame: Day 3 (600 mg)
Maximum Concentration (Cmax) at Day 21 (400 mg)
Time frame: Day 21 (400 mg)

Results and safety

Results posted to the registry on 20 May 2009, 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 600 mg	10	1
Vorinostat 400 mg	6	0

Primary outcome: Number of Participants With a Dose Limiting Toxicity (DLT)

Time frame: 21 Days (first cycle). Number. Unit: Participants

Measure	Vorinostat 600 mg n = 10	Vorinostat 400 mg n = 4
Value	0	2

Population analysed: Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vorinostat 600 mg	4 of 10 (40%)	10 of 10 (100%)	Not reported
Vorinostat 400 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22234637Doi T, Hamaguchi T, Shirao K, Chin K, Hatake K, Noguchi K, Otsuki T, Mehta A, Ohtsu A. Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial. Int J Clin Oncol. 2013 Feb;18(1):87-95. doi: 10.1007/s10147-011-0348-6. Epub 2012 Jan 11.

Related trials for Tumors

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

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 Director 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 Tumors, 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 1 inclusion and 4 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 27 Aug 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 20 May 2009). 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?

Number of Participants With a Dose Limiting Toxicity (DLT) (time frame: 21 Days (first cycle)). 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 NCT00373490, 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 27 Aug 2015.