Solid TumorsPhase 1NCT01071018
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
A Phase 1 study testing MK2206 every other day and MK2206 once weekly in people with Solid Tumors, run by Merck Sharp & Dohme LLC.
Trial summary
This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- MK2206 every other day and MK2206 once weekly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
- Has adequate organ function
- Is ECOG Performance Scale 0-1
- Has a negative urine pregnancy test if patient is female
- Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis
Who cannot join
- Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
- Is currently participating or has participated in a study with an investigational compound or device within 28 days
- Has a primary central nervous system tumor
- Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
- Is a known diabetic who is taking insulin or oral antidiabetic therapy
- Is pregnant or breastfeeding or planning to become pregnant during the study
- Is positive HIV antibody, HBs antigen or HCV antibody
About this study
Official title: A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors
This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.
- Conditions
- Solid Tumors
- Being tested
- MK2206 every other day, MK2206 once weekly
- Keywords
- locally advanced or metastatic solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK2206 every other dayDrug
Also called MK2206
Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.
MK2206 once weeklyDrug
Also called MK2206
Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.
| Study group | Role | What they receive |
|---|---|---|
| QOD Schedule | Experimental | QOD Schedule, MK2206 every other day Receives: Drug: MK2206 every other day |
| QW Schedule | Experimental | QW Schedule, MK2206 once weekly Receives: Drug: MK2206 once weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
Measured: Day 1 - Day 28 (Cycle 1)
Secondary outcomes (1)
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax
Measured: Day 1 - Day 28 (Cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071018
- Sponsor's protocol ID
- 2206-007
- Other IDs
- 2010_509
- Status last verified
- Sep 2015
- First submitted
- 17 Feb 2010
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24.
PubMed 26104654
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01071018
- Acronym / sponsor ID
- 2206-007
- Conditions
- Solid Tumors
- Keywords
- locally advanced or metastatic solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QOD Schedule | Experimental | Drug: MK2206 every other dayQOD Schedule, MK2206 every other day |
| QW Schedule | Experimental | Drug: MK2206 once weeklyQW Schedule, MK2206 once weekly |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
- Has adequate organ function
- Is ECOG Performance Scale 0-1
- Has a negative urine pregnancy test if patient is female
- Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis
Key exclusion criteria (7 listed)
- Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
- Is currently participating or has participated in a study with an investigational compound or device within 28 days
- Has a primary central nervous system tumor
- Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
- Is a known diabetic who is taking insulin or oral antidiabetic therapy
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 |
|---|---|---|
| MK2206 every other dayAlso: MK2206Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles. | Drug | QOD Schedule |
| MK2206 once weeklyAlso: MK2206Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles. | Drug | QW Schedule |
Primary outcome
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
Time frame: Day 1 - Day 28 (Cycle 1)
1 secondary outcome
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax
Time frame: Day 1 - Day 28 (Cycle 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Background: PubMed 26104654Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24.
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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 MK2206 every other day and MK2206 once weekly in people with Solid 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 5 inclusion and 7 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 7 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) (time frame: Day 1 - Day 28 (Cycle 1)). 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 NCT01071018, 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 7 Sep 2015.