NeoplasmsPhase 1NCT00880568
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
A Phase 1 study testing MK-1496 in people with Neoplasms and Malignant, run by Merck Sharp & Dohme LLC.
Trial summary
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MK-1496
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jan 2011
- 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
- Participant must have 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.
- Participant must have Performance Status 0 or 1.
- Participant must have adequate organ function.
Who cannot join
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
- Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
- Participant has known hypersensitivity to the components of study drug or its analogs.
- Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
About this study
Official title: A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
- Being tested
- MK-1496
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1496Drug
MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle
MK-1496Drug
MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| MK-1496 20 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle Receives: Drug: MK-1496 |
| MK-1496 40 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle Receives: Drug: MK-1496 |
| MK-1496 80 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle Receives: Drug: MK-1496 |
| MK-1496 120 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle Receives: Drug: MK-1496 |
| MK-1496 20 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Receives: Drug: MK-1496 |
| MK-1496 40 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Receives: Drug: MK-1496 |
| MK-1496 80 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Receives: Drug: MK-1496 |
| MK-1496 100 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Receives: Drug: MK-1496 |
| MK-1496 120 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Receives: Drug: MK-1496 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Measured: Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Number of Participants With Any Clinical or Laboratory Adverse Event
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Measured: First dose up to 30 days after last dose (up to 2 years)
Secondary outcomes (3)
Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.
AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5.
Measured: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.
AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5.
Measured: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.
AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4.
Measured: Cycle 1, Day 3 (Hour 0 through Hour 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2010
- Study completionJan 2011
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 NeoplasmsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880568
- Sponsor's protocol ID
- 1496-002
- Other IDs
- 2009_575
- Status last verified
- Feb 2015
- First submitted
- 10 Apr 2009
- Last updated
- 19 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT00880568
- Acronym / sponsor ID
- 1496-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| MK-1496 20 mg (21-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
| MK-1496 40 mg (21-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
| MK-1496 80 mg (21-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
| MK-1496 120 mg (21-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
| MK-1496 20 mg (28-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 40 mg (28-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 80 mg (28-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 100 mg (28-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 120 mg (28-Day Cycle) | Experimental | Drug: MK-1496Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must have 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.
- Participant must have Performance Status 0 or 1.
- Participant must have adequate organ function.
Key exclusion criteria (4 listed)
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
- Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
- Participant has known hypersensitivity to the components of study drug or its analogs.
- Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
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 |
|---|---|---|
| MK-1496MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle | Drug | MK-1496 120 mg (21-Day Cycle), MK-1496 20 mg (21-Day Cycle), MK-1496 40 mg (21-Day Cycle), MK-1496 80 mg (21-Day Cycle) |
| MK-1496MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle | Drug | MK-1496 100 mg (28-Day Cycle), MK-1496 120 mg (28-Day Cycle), MK-1496 20 mg (28-Day Cycle), MK-1496 40 mg (28-Day Cycle), MK-1496 80 mg (28-Day Cycle) |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Number of Participants With Any Clinical or Laboratory Adverse Event
Time frame: First dose up to 30 days after last dose (up to 2 years)
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
3 secondary outcomes
Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
Time frame: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
Time frame: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
Time frame: Cycle 1, Day 3 (Hour 0 through Hour 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1496 in people with Neoplasms and Malignant, 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 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 19 Feb 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 26 Oct 2012). 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 (DLTs) (time frame: Cycle 1 (up to 21 or 28 days, depending on treatment arm)). 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?
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 19 Feb 2015.