Non-Small Cell Lung CancerPhase 1NCT00423449

Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

A Phase 1 study testing vorinostat, Gemcitabine and Platinum-based agent in people with Non-Small Cell Lung 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.

Official record

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Trial summary

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: vorinostat, Gemcitabine and Platinum-based agent
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: No sites listed yet
Study dates: Mar 2007to Apr 2010
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 must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment

Who cannot join

Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor

About this study

Official title: A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Conditions: Non-Small Cell Lung Cancer
Being tested: vorinostat, Gemcitabine, Platinum-based agent
Keywords: Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

vorinostatDrug
Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days
GemcitabineDrug
Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle
Platinum-based agentDrug
Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.

Study groups in NCT00423449
Study group	Role	What they receive
Vorinostat + Gemcitabine + Platinum-based agent	Experimental	Not described Receives: Drug: vorinostat; Drug: Gemcitabine; Drug: Platinum-based agent

What is being measured

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

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin
DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.
Measured: every 21 days (every cycle), up to 126 days (6 cycles)
Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease
Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.
The MTD was 400 mg for up to 10 days in 21-day cycles.
Measured: every 21 days (every cycle), up to 126 days (6 cycles)

Secondary outcomes (2)

Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)
An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).
Measured: every 21 days (every cycle), up to 126 days (6 cycles)
Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).
Measured: every 21 days (every cycle), up to 126 days (6 cycles)

Timeline

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

Mar 2007Apr 2010

First posted18 Jan 2007 (estimated)
Study startMar 2007
Primary completionApr 2010
Study completionApr 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.
Other trials for Non-Small Cell Lung 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00423449
Sponsor's protocol ID: 0683-058
Other IDs: 2006_528
Status last verified: Feb 2016
First submitted: 17 Jan 2007
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

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 Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00423449
Acronym / sponsor ID: 0683-058
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Jan 2007 (estimated)
Results: Posted 2 Aug 2011

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 trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Study design

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

Arm	Type	Receives
Vorinostat + Gemcitabine + Platinum-based agent	Experimental	Drug: vorinostat, Drug: Gemcitabine, Drug: Platinum-based agent

Who may qualify

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

Key inclusion criteria (1 listed)

Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment

Key exclusion criteria (1 listed)

Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor

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
vorinostatDose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days	Drug	Vorinostat + Gemcitabine + Platinum-based agent
GemcitabineDose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle	Drug	Vorinostat + Gemcitabine + Platinum-based agent
Platinum-based agentCisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.	Drug	Vorinostat + Gemcitabine + Platinum-based agent

Primary outcome

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin
Time frame: every 21 days (every cycle), up to 126 days (6 cycles)
DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.
Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease
Time frame: every 21 days (every cycle), up to 126 days (6 cycles)
Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment. The MTD was 400 mg for up to 10 days in 21-day cycles.

2 secondary outcomes

Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)
Time frame: every 21 days (every cycle), up to 126 days (6 cycles)
Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)
Time frame: every 21 days (every cycle), up to 126 days (6 cycles)

Results and safety

Results posted to the registry on 2 Aug 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
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin	4	1
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin	6	2
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin	17	2
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin	27	5
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin	7	0

Primary outcome: Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin

Time frame: every 21 days (every cycle), up to 126 days (6 cycles). Number. Unit: Participants

Measure	Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin n = 4	Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin n = 6	Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin n = 17	Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin n = 27	Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin n = 7
Value	0	1	0	0	1

Primary outcome: Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease

Time frame: every 21 days (every cycle), up to 126 days (6 cycles). Number. Unit: mg

Measure	All Participants n = 61
Value	400

2 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
MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin	3 of 4 (75%)	4 of 4 (100%)	Not reported
MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin	4 of 6 (66.7%)	6 of 6 (100%)	Not reported
MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin	10 of 18 (55.6%)	17 of 18 (94.4%)	Not reported
MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin	18 of 27 (66.7%)	27 of 27 (100%)	Not reported
MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin	4 of 7 (57.1%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, Gemcitabine and Platinum-based agent in people with Non-Small Cell Lung 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 1 inclusion and 1 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 4 Feb 2016. 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 2 Aug 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?

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin (time frame: every 21 days (every cycle), up to 126 days (6 cycles)). The study lists 2 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 NCT00423449.

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 4 Feb 2016.