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

A Phase 2 study testing vorinostat in people with Advanced Cancer, 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 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer
What is being tested?: vorinostat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: Aug 2005to Jun 2010
Phase: Phase 2
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 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

Who cannot join

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

About this study

Official title: A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers

Conditions: Advanced Cancer
Being tested: vorinostat

What participants receive

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

vorinostatDrug
Also called MK-0683
All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.

Study groups in NCT00907738
Study group	Role	What they receive
Vorinostat	Experimental	Not described Receives: Drug: vorinostat

What is being measured

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

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.
Measured: 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)

Timeline

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

Aug 2005Jun 2010

First posted25 May 2009 (estimated)
Study startAug 2005
Primary completionJun 2010
Study completionJun 2010

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 CancerStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00907738
Sponsor's protocol ID: 0683-007
Other IDs: 2009_595
Status last verified: May 2015
First submitted: 21 May 2009
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19951879

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

Enrolling by invitationPhase 2
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Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
ClinicalTrials.gov ID: NCT00907738
Acronym / sponsor ID: 0683-007
Conditions: Advanced Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 14 Jul 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vorinostat	Experimental	Drug: vorinostat

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 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

Key exclusion criteria (2 listed)

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

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-0683All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.	Drug	Vorinostat

Primary outcome

Percent of Participants With a Serious Drug-related Adverse Event (AE)
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)
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.

Results and safety

Results posted to the registry on 14 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Base Protocol 001	13	0
Base Protocol 006	1	0
Base Protocol 008	7	0
Base Protocol 012	4	0
Base Protocol 013	2	0

Primary outcome: Percent of Participants With a Serious Drug-related Adverse Event (AE)

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). Number. Unit: percent of participants

Measure	Base Protocol 001 n = 13	Base Protocol 006 n = 1	Base Protocol 008 n = 7	Base Protocol 012 n = 4	Base Protocol 013 n = 2
Value	7.7	0	0	0	0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])	4 of 13 (30.8%)	6 of 13 (46.2%)	Not reported
Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])	1 of 1 (100%)	0 of 1 (0%)	Not reported
Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])	1 of 7 (14.3%)	2 of 7 (28.6%)	Not reported
Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)	0 of 1 (0%)	0 of 1 (0%)	Not reported
Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)	1 of 1 (100%)	1 of 1 (100%)	Not reported
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)	0 of 1 (0%)	0 of 1 (0%)	Not reported
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)	0 of 1 (0%)	0 of 1 (0%)	Not reported
Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)	0 of 1 (0%)	1 of 1 (100%)	Not reported
Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)	0 of 1 (0%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19951879Duvic 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.

Related trials for Advanced Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

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 2 study testing vorinostat in people with Advanced Cancer, 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 2 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 21 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Jul 2011). 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?

Percent of Participants With a Serious Drug-related Adverse Event (AE) (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)). 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 NCT00907738, 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 21 May 2015.