A Phase 2 interventional study of Akt inhibitor MK2206 and laboratory biomarker analysis in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Among 22 studies in Lymphoma, Extranodal NK-T-Cell by National Cancer Institute (NCI) — none open to participants now, 1 under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · National Cancer Institute (NCI).
Among the 22 studies in Lymphoma, Extranodal NK-T-Cell by National Cancer Institute (NCI), this one is the 3rd largest by enrollment, is one of 3 that started in 2010, is one of 3 in phase 2, and was the 17th registered.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
Browse Lymphoma, Extranodal NK-T-Cell studies →None of the 22 studies in Lymphoma, Extranodal NK-T-Cell by National Cancer Institute (NCI) is open now. The open studies under Lymphoma, Extranodal NK-T-Cell, anywhere →
Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 4
First in 2003; this study’s year is marked. 3 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Median enrollment 34 across the 22 interventional studies. Of the 20 that completed or were terminated, 6 (30%) have results posted.
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National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Lymphoma, Extranodal NK-T-Cell by National Cancer Institute (NCI), from their registry updates:
Nothing recorded among them since 2026-09-25.
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This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Determine the objective response rate (ORR) of MK-2206 (Akt inhibitor MK2206) in patients with relapsed/refractory lymphoma.
SECONDARY OBJECTIVES:
I. Assess the progression free survival (PFS) of MK-2206 in patients with relapsed/refractory lymphoma.
II. Assess the safety and tolerability of MK-2206 monotherapy. III. Examine pretreatment phosphorylated v-akt murine thymoma viral oncogene homolog 1 (pAkt) protein expression by immunohistochemistry, and correlate the results with treatment response.
IV. Examine the effect of therapy on serum cytokines and chemokines that regulate the tumor-promoting inflammatory process and/or immunity in patients with relapsed/refractory lymphoma, and correlate the results with treatment response.
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive Akt inhibitor MK2206 PO once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206 · Other: laboratory biomarker analysis
Given PO
Also known as: MK2206
Correlative studies
Objective Response Rate (ORR)
Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regression of measurable disease and no new sites, 50% decrease in , sum of the product of the diameters SPD of up to 6 largest dominant masses; no increase in size of other nodes(a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT, 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen, Irrelevant if positive prior to therapy; cell type should be specified.
Time frame: 4 months
Progression-free Survival
Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
Time frame: From treatment start date until the date of first documented progression or date of death from any cause, whichever came first.
Duration of Response
Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
Time frame: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Overall Survival
Number of surviving participants without disease progression or death for any reason at one year post treatment. Kaplan-Meier method was used.
Time frame: From the start of treatment to death or 30 days after removal from the study whichever occurs first
Number of Participants With Change in Cytokine Levels With p Values <0.05
The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Time frame: Baseline to up to 30 days post-treatment
Number of Participants With Change in Chemokine Levels With p Values <0.05
The changes in the chemokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Time frame: Baseline to up to 30 days post-treatment
Number of Participants With Change in Biomarker Levels With p Values <0.05
The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Time frame: Baseline to up to 30 days post-treatment
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Toxicity data will be summarized by frequency tables.
Time frame: Up to 30 days
Recruitment Period: December 10, 2010 to February 20, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
| Milestone | Akt Inhibitor MK2206 |
|---|---|
| Started | 60 |
| Completed | 59 |
| Not completed | 1 |
| Withdrew: Ineligible | 1 |
Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regression of measurable disease and no new sites, 50% decrease in , sum of the product of the diameters SPD of up to 6 largest dominant masses; no increase in size of other nodes(a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT, 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen, Irrelevant if positive prior to therapy; cell type should be specified.
| Participants | Akt Inhibitor MK2206 |
|---|---|
| Complete Response (CR) | 2 |
| Partial Response (PR) | 6 |
Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
| months | Akt Inhibitor MK2206 |
|---|---|
| Progression-free Survival | 2.8 (2 to 6) |
Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
| months | Akt Inhibitor MK2206 |
|---|---|
| Duration of Response | 5.8 (1.8 to 11.6) |
Number of surviving participants without disease progression or death for any reason at one year post treatment. Kaplan-Meier method was used.
No measurements were reported for this outcome.
The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
| Participants | Akt Inhibitor MK2206 |
|---|---|
| Number of Participants With Change in Cytokine Levels With p Values <0.05 | 36 |
The changes in the chemokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
| Participants | Akt Inhibitor MK2206 |
|---|---|
| Number of Participants With Change in Chemokine Levels With p Values <0.05 | 0 |
The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
| Participants | Akt Inhibitor MK2206 |
|---|---|
| Number of Participants With Change in Biomarker Levels With p Values <0.05 | 0 |
Toxicity data will be summarized by frequency tables.
| Participants | Akt Inhibitor MK2206 |
|---|---|
| Fatigue | 12 |
| Anorexia | 4 |
| Aspartate aminotransferase elevation | 4 |
| Constipation | 3 |
| Diarrhea | 4 |
| Nausea | 9 |
| Hyperglycemia | 34 |
| Elevated creatinine | 4 |
| Conjunctivitis | 4 |
| Rash | 31 |
| Dry skin | 4 |
| Pruritus | 6 |
| Anemia | 5 |
| Thrombocytopenia | 15 |
| Neutropenia | 10 |
| Lymphopenia | 13 |
Collected over Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Akt Inhibitor MK2206) | — | 5/60 (8.3%) | 59/60 (98.3%) |
| Event | Treatment (Akt Inhibitor MK2206) |
|---|---|
| Lymphocyte count decreasedBlood and lymphatic system disorders | 3/60 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 1/60 |
| HyperglycemiaMetabolism and nutrition disorders | 1/60 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 1/60 |
| HypercalcemiaMetabolism and nutrition disorders | 1/60 |
| AnemiaBlood and lymphatic system disorders | 1/60 |
| Event | Treatment (Akt Inhibitor MK2206) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 11/60 |
| HyperglycemiaBlood and lymphatic system disorders | 5/60 |
| FatigueGeneral disorders | 4/60 |
| HypertensionCardiac disorders | 4/60 |
| Aspartate aminotransferase increasedBlood and lymphatic system disorders | 3/60 |
| DepressionNervous system disorders | 3/60 |
| Gastrointestinal disordersGastrointestinal disorders | 3/60 |
| HypoalbuminemiaBlood and lymphatic system disorders | 3/60 |
| LeukocytosisBlood and lymphatic system disorders | 3/60 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 3/60 |
| Age, Continuous(years) | Treatment (Akt Inhibitor MK2206) |
|---|---|
| Median | 58 (21 to 82) |
| Sex: Female, Male(Participants) | Treatment (Akt Inhibitor MK2206) |
|---|---|
| Female | 21 |
| Male | 39 |
| Region of Enrollment(participants) | Treatment (Akt Inhibitor MK2206) |
|---|---|
| United States | 60 |
The record gives a start of Dec 2010, a primary completion of Jul 2014 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2015, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MK 2206
Lymphoma, Extranodal NK-T-Cell →
National Cancer Institute (NCI) →