Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT NCT01481129)
NCT ID: NCT01481129
Last Updated: 2017-09-28
Results Overview
Rate of CR + PR according to Cheson 2007 after 4 months of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2017-09-28
Participant Flow
Participant milestones
| Measure |
Treatment (Akt Inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Akt Inhibitor MK2206)
n=22 Participants
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
64.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsRate of CR + PR according to Cheson 2007 after 4 months of treatment
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=22 Participants
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)
|
0 objective response
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: No responses were observed
Described in responding subjects using descriptive statistics (median, extreme values, etc.).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of inclusion to the date of death from any cause, assessed up to 4 yearsAnalyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=22 Participants
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Survival
|
9.6 months
Interval 2.8 to 18.8
|
SECONDARY outcome
Timeframe: From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 yearsAnalyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=22 Participants
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression-free Survival (PFS)
|
1.71 months
Interval 0.8 to 1.8
|
SECONDARY outcome
Timeframe: Up to 30 daysOutcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=19 Participants
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
19 Participants
|
Adverse Events
Treatment (Akt Inhibitor MK2206)
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=19 participants at risk
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
Gastro intestinal bleeding
|
5.3%
1/19 • 12 months
|
|
Endocrine disorders
Hyperglycemia
|
5.3%
1/19 • 12 months
|
|
Injury, poisoning and procedural complications
Drug overdose accidental
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
Pericarditis
|
5.3%
1/19 • 12 months
|
|
Vascular disorders
Pulmonary embolism
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.3%
1/19 • 12 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.3%
1/19 • 12 months
|
|
Immune system disorders
Drug allergy
|
5.3%
1/19 • 12 months
|
|
General disorders
General physical health deterioration
|
5.3%
1/19 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Distress respiratory
|
5.3%
1/19 • 12 months
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
5.3%
1/19 • 12 months
|
|
General disorders
Death
|
5.3%
1/19 • 12 months
|
Other adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=19 participants at risk
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Cardiac disorders
arythmia
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
heart palpitations
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
tachycardia
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
mouth ulcers
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
cutaneous eruption
|
15.8%
3/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
cutaneous erythema
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
papule
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
prurigo
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
prurit
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
cutaneous rash
|
5.3%
1/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
15.8%
3/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
toxidermia
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
dysgueusia
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
encephalopathy
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
paresthesia
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
diarrhea
|
21.1%
4/19 • 12 months
|
|
Gastrointestinal disorders
digestive bleeding
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
nausea
|
21.1%
4/19 • 12 months
|
|
Gastrointestinal disorders
stomatitis
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
vomiting
|
10.5%
2/19 • 12 months
|
|
Blood and lymphatic system disorders
uremic hemolytic syndrome
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
hypertension
|
10.5%
2/19 • 12 months
|
|
Cardiac disorders
hypotension
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
thrombosis
|
5.3%
1/19 • 12 months
|
|
Investigations
increase bilrubin
|
5.3%
1/19 • 12 months
|
|
Investigations
creatinine clearance decrease
|
10.5%
2/19 • 12 months
|
|
Investigations
creatinine increase
|
5.3%
1/19 • 12 months
|
|
Investigations
eosinophil increase
|
5.3%
1/19 • 12 months
|
|
Investigations
GGT increase
|
10.5%
2/19 • 12 months
|
|
Investigations
anemia
|
10.5%
2/19 • 12 months
|
|
Investigations
QT prolongation
|
10.5%
2/19 • 12 months
|
|
Investigations
leucopenia
|
15.8%
3/19 • 12 months
|
|
Investigations
lymphopenia
|
15.8%
3/19 • 12 months
|
|
Investigations
neutrophil decrease
|
26.3%
5/19 • 12 months
|
|
Investigations
alkaline phosphatase increase
|
5.3%
1/19 • 12 months
|
|
Investigations
thrombopenia
|
26.3%
5/19 • 12 months
|
|
Investigations
SGOT increase
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
albumine decrease
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
calcium decrease
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
glycaemia increase
|
31.6%
6/19 • 12 months
|
|
Metabolism and nutrition disorders
appetite loss
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
decreases phosphorus
|
21.1%
4/19 • 12 months
|
|
General disorders
asthenia
|
21.1%
4/19 • 12 months
|
|
General disorders
chest pain
|
5.3%
1/19 • 12 months
|
|
General disorders
fatigue
|
15.8%
3/19 • 12 months
|
|
General disorders
lower limbs oedema
|
5.3%
1/19 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60