Recurrent Nasopharyngeal CarcinomaPhase 2MC1079NCT01370070
MK-2206 in Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing MK-2206 in people with Recurrent Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- MK-2206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2011to Jan 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 year, able to give written informed consent.
- History of histologically or cytologically confirmed non-keratinizing NPC that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery.
- Patients must have progressed within 24 months of receiving one or two prior line of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as Cisplatin, Carboplatin or oxaliplatin.
- Adequate organ reserve: neutrophils >1.5x109/L, platelets ≥100 x109/L, hemoglobin ≥9 g/dL, serum alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) or ALT< 5 x ULN in the presence of liver metastases, serum bilirubin < 2.5 x ULN, serum creatinine < 1.5 x ULN.
- Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST ver 1.1).
Who cannot join
- Chemotherapy, radiotherapy (except to bone metastases) or investigational treatment within 4 weeks of enrollment.
- Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial.
- Cardiovascular: baseline QTcF > 450 msec (male) or QTcF >470 msec (female) Left bundle branch block, 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, significant sinus bradycardia (< 50bpm) . However, patients with asymptomatic right bundle branch block or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are NOT excluded..
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- MK-2206
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2206Drug
200mg weekly repeated q 28 days
| Study group | Role | What they receive |
|---|---|---|
| MK-2206 | Experimental | Not described Receives: Drug: MK-2206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
Measured: 3 years
Secondary outcomes (7)
Adverse events
Measured: 2 Years
Overall survival
Measured: 3 years
Progression-free survival
Measured: 3 Years
RECIST-based subjective response
Measured: 3 Years
Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life
Measured: 3 years
treatment tolerability
Measured: 2 years
duration of response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2016
- Study completionJan 2017
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 Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Brigette Ma, MD, FRACP, Principal investigator, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370070
- Sponsor's protocol ID
- NPC024
- Acronym
- MC1079
- Status last verified
- Jan 2017
- First submitted
- 12 May 2011
- Last updated
- 13 Jan 2017
- Results posted
- No
Publications
Ma BB, Goh BC, Lim WT, Hui EP, Tan EH, Lopes Gde L, Lo KW, Li L, Loong H, Foster NR, Erlichman C, King AD, Kam MK, Leung SF, Chan KC, Chan AT. Multicenter phase II study of the AKT inhibitor MK-2206 in recurrent or metastatic nasopharyngeal carcinoma from patients in the mayo phase II consortium and the cancer therapeutics research group (MC1079). Invest New Drugs. 2015 Aug;33(4):985-91. doi: 10.1007/s10637-015-0264-0. Epub 2015 Jun 19.
PubMed 26084990
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01370070
- Acronym / sponsor ID
- MC1079 / NPC024
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Jun 2011 (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.
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-2206 | Experimental | Drug: MK-2206 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged > 18 year, able to give written informed consent.
- History of histologically or cytologically confirmed non-keratinizing NPC that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery.
- Patients must have progressed within 24 months of receiving one or two prior line of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as Cisplatin, Carboplatin or oxaliplatin.
- Adequate organ reserve: neutrophils >1.5x109/L, platelets ≥100 x109/L, hemoglobin ≥9 g/dL, serum alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) or ALT< 5 x ULN in the presence of liver metastases, serum bilirubin < 2.5 x ULN, serum creatinine < 1.5 x ULN.
- Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST ver 1.1).
Key exclusion criteria (4 listed)
- Chemotherapy, radiotherapy (except to bone metastases) or investigational treatment within 4 weeks of enrollment.
- Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial.
- Cardiovascular: baseline QTcF > 450 msec (male) or QTcF >470 msec (female) Left bundle branch block, 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, significant sinus bradycardia (< 50bpm) . However, patients with asymptomatic right bundle branch block or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are NOT excluded..
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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-2206200mg weekly repeated q 28 days | Drug | MK-2206 |
Primary outcome
The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
Time frame: 3 years
7 secondary outcomes
Adverse events
Time frame: 2 Years
Overall survival
Time frame: 3 years
Progression-free survival
Time frame: 3 Years
RECIST-based subjective response
Time frame: 3 Years
Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life
Time frame: 3 years
treatment tolerability
Time frame: 2 years
duration of response
Time frame: 3 years
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 13 Jan 2017.
- Derived from this study: PubMed 26084990Ma BB, Goh BC, Lim WT, Hui EP, Tan EH, Lopes Gde L, Lo KW, Li L, Loong H, Foster NR, Erlichman C, King AD, Kam MK, Leung SF, Chan KC, Chan AT. Multicenter phase II study of the AKT inhibitor MK-2206 in recurrent or metastatic nasopharyngeal carcinoma from patients in the mayo phase II consortium and the cancer therapeutics research group (MC1079). Invest New Drugs. 2015 Aug;33(4):985-91. doi: 10.1007/s10637-015-0264-0. Epub 2015 Jun 19.
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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.
Brigette Ma, MD, FRACP principal investigator
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-2206 in people with Recurrent Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint (time frame: 3 years). 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 NCT01370070, 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 13 Jan 2017.