Trial Outcomes & Findings for Selumetinib and Akt Inhibitor MK2206 in Treating Patients With Stage III or Stage IV Melanoma Who Failed Prior Therapy With Vemurafenib or Dabrafenib (NCT NCT01519427)
NCT ID: NCT01519427
Last Updated: 2014-06-18
Results Overview
Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
TERMINATED
PHASE2
2 participants
On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)
2014-06-18
Participant Flow
Subjects were recruited from January 2012 through February 2013.
Four potential subjects consented. Two were ineligible.
Participant milestones
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Overall Study
disease progression
|
2
|
Baseline Characteristics
Selumetinib and Akt Inhibitor MK2206 in Treating Patients With Stage III or Stage IV Melanoma Who Failed Prior Therapy With Vemurafenib or Dabrafenib
Baseline characteristics by cohort
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 Participants
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 14 • n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)Population: All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.
Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
Outcome measures
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 Participants
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Objective Response
Complete response
|
0 participants
|
|
Objective Response
Partial response
|
0 participants
|
|
Objective Response
Progressive disease
|
1 participants
|
|
Objective Response
Stable disease
|
1 participants
|
SECONDARY outcome
Timeframe: Before initiation of treatment and at 7-14 days, up to 2 yearsPopulation: This clinical trial was terminated early. The investigators did not perform any biomarker expression analyses.
Pre-treatment tumor biopsy tissue and blood and day 7-14 tumor biopsy tissue and blood will be examined by immunohistochemistry for expression and phosphorylation of the proteins pERK, pMEK, pAKT, Ki67, pRpS6, CRAF, cyclin D, PDGFr, pPDGFr. IGFr1, and COT/Tp12 for changes from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On-study to lesser of date of progression or date of death from any cause, up to 2 yearsPopulation: All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: \>= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions
Outcome measures
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 Participants
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Progression-free Survival (PFS)
|
105 days
Interval 42.0 to 168.0
|
SECONDARY outcome
Timeframe: On-study date to date of death from any cause, up to 2 yearsPopulation: All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.
Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).
Outcome measures
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 Participants
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Overall Survival
|
153 days
Interval 117.0 to 189.0
|
Adverse Events
Treatment (Selumetinib and Akt Inhibitor MK2206)
Serious adverse events
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 participants at risk
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Renal and urinary disorders
Urinary tract obstruction
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Blood and lymphatic system disorders
anemia
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Musculoskeletal and connective tissue disorders
pelvic pain
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Renal and urinary disorders
acute renal failure
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
Other adverse events
| Measure |
Treatment (Selumetinib and Akt Inhibitor MK2206)
n=2 participants at risk
Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
|
|---|---|
|
Nervous system disorders
Nervous system disorders - Other
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
50.0%
1/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Blood and lymphatic system disorders
anemia
|
50.0%
1/2 • Number of events 5 • day 0 through day 168 (week 24)
|
|
Cardiac disorders
electrocardiogram QT corrected interval prolonged
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Gastrointestinal disorders
vomiting
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Infections and infestations
bladder infection
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Infections and infestations
urinary tract infection
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Investigations
alanine aminotransferase increased
|
100.0%
2/2 • Number of events 6 • day 0 through day 168 (week 24)
|
|
Investigations
aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Investigations
creatinine increased
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Metabolism and nutrition disorders
anorexia
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Metabolism and nutrition disorders
hyperglycemia
|
100.0%
2/2 • Number of events 5 • day 0 through day 168 (week 24)
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
50.0%
1/2 • Number of events 3 • day 0 through day 168 (week 24)
|
|
Metabolism and nutrition disorders
hypokalemia
|
50.0%
1/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Metabolism and nutrition disorders
hyponatremia
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
General disorders
pain
|
100.0%
2/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Eye disorders
blurred vision
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Eye disorders
pain eye
|
50.0%
1/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Renal and urinary disorders
hematuria
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Vascular disorders
lymphedema
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
General disorders
chills
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
General disorders
fatigue
|
50.0%
1/2 • Number of events 2 • day 0 through day 168 (week 24)
|
|
Musculoskeletal and connective tissue disorders
pain extremity
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Cardiac disorders
Atrial fibrillation
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • day 0 through day 168 (week 24)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60