NCT01258998 · STUDY IN CONTEXT

Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Based on intent-to-treat analysis.

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secondary · POSTED

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.

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

Number of surviving participants without disease progression or death for any reason at one year post treatment. Kaplan-Meier method was used.

PI is not available, therefore, no data is available for reporting in this section due to the overall survival was not an outcome to be measured initially. All efforts were made to retrieve data.

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secondary · POSTED

The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.

Source null

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secondary · POSTED

The changes in the chemokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-small-intestinal-lymphoma
nct id: NCT01258998
trial label: Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0000
source section id
NCT01258998-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR)
endpoint definition
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 origin
4 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Based on intent-to-treat analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0001
source section id
NCT01258998-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
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 origin
From treatment start date until the date of first documented progression or date of death from any cause, whichever came first.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0002
source section id
NCT01258998-om-0002
source outcome index
2
endpoint
Duration of Response
endpoint definition
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 origin
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.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0003
source section id
NCT01258998-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Number of surviving participants without disease progression or death for any reason at one year post treatment. Kaplan-Meier method was used.
time origin
From the start of treatment to death or 30 days after removal from the study whichever occurs first
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PI is not available, therefore, no data is available for reporting in this section due to the overall survival was not an outcome to be measured initially. All efforts were made to retrieve data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0004
source section id
NCT01258998-om-0004
source outcome index
4
endpoint
Number of Participants With Change in Cytokine Levels With p Values <0.05
endpoint definition
The changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
time origin
Baseline to up to 30 days post-treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0005
source section id
NCT01258998-om-0005
source outcome index
5
endpoint
Number of Participants With Change in Chemokine Levels With p Values <0.05
endpoint definition
The changes in the chemokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
time origin
Baseline to up to 30 days post-treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0000
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0001
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0002
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0003
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0004
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
outcome key
om-0005
arm key
OG000
arm label
Akt Inhibitor MK2206
regimen
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01258998-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01258998
harm key
EG000
source section id
NCT01258998-ae
event group key
EG000
event group label
Treatment (Akt Inhibitor MK2206)
serious affected
5
serious at risk
60
other affected
59
other at risk
60
frequency threshold
0
collection period
Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice