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Trial record 2 of 21 for:    "Acinar Cell Carcinoma" | "Immunosuppressive Agents"

Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy (S1115)

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ClinicalTrials.gov Identifier: NCT01658943
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Acinar Cell Carcinoma
Pancreatic Ductal Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer
Interventions Drug: Akt Inhibitor MK2206
Drug: Fluorouracil
Drug: Oxaliplatin
Drug: Selumetinib
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 70 67
Eligible 63 58
Eligible and Began Protocol Therapy 62 58
Completed 0 0
Not Completed 70 67
Reason Not Completed
Adverse Event             6             13
Withdrawal by Subject             9             2
Progression/Relapse             39             40
Death             4             2
not protocol specified             4             1
Not eligible             7             9
Withdrew prior to beginning protocol Tx             1             0
Arm/Group Title mFOLFOX MK2206 and Selumetinib Total
Hide Arm/Group Description Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 62 58 120
Hide Baseline Analysis Population Description
Eligible and analyzable patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 62 participants 58 participants 120 participants
65.6
(34.2 to 82.8)
69.4
(54.2 to 88.0)
67.3
(34.2 to 88.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
Female
40
  64.5%
23
  39.7%
63
  52.5%
Male
22
  35.5%
35
  60.3%
57
  47.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
Hispanic or Latino
3
   4.8%
1
   1.7%
4
   3.3%
Not Hispanic or Latino
59
  95.2%
57
  98.3%
116
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   6.5%
4
   6.9%
8
   6.7%
Native Hawaiian or Other Pacific Islander
1
   1.6%
1
   1.7%
2
   1.7%
Black or African American
7
  11.3%
4
   6.9%
11
   9.2%
White
50
  80.6%
49
  84.5%
99
  82.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Prior Systemic Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
4 months or less 23 22 45
more than 4 months 39 36 75
Liver Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
Yes 39 43 82
No 23 15 38
1.Primary Outcome
Title Overall Survival
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients.
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description:
Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 62 58
Median (95% Confidence Interval)
Unit of Measure: months
6.7
(6.0 to 8.3)
3.9
(3.5 to 4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection mFOLFOX, MK2206 and Selumetinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description:
Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1 0
Alanine aminotransferase increased 0 4
Alkaline phosphatase increased 0 2
Anemia 2 3
Anorexia 1 1
Aspartate aminotransferase increased 0 3
Blood bilirubin increased 1 0
Cognitive disturbance 0 1
Dehydration 1 6
Device related infection 1 0
Diarrhea 4 4
Edema face 0 1
Encephalopathy 0 1
Erythema multiforme 0 1
Erythroderma 0 1
Fatigue 8 7
Generalized muscle weakness 0 1
Hepatic failure 0 1
Hyperglycemia 1 7
Hypertension 2 5
Hypokalemia 1 1
Hypomagnesemia 1 0
Hyponatremia 1 4
Hypophosphatemia 0 1
Hypotension 1 1
Hypoxia 0 1
Left ventricular systolic dysfunction 0 1
Lung infection 1 1
Lymphocyte count decreased 8 0
Mucositis oral 1 4
Multi-organ failure 0 1
Nausea 3 0
Neoplasms benign, malignant and unspecified 0 2
Neutrophil count decreased 4 0
Platelet count decreased 1 0
Rash acneiform 0 5
Rash maculo-papular 0 7
Skin infection 0 1
Soft tissue infection 0 1
Stevens-Johnson syndrome 0 1
Syncope 0 1
Vomiting 3 1
Weight loss 1 0
White blood cell decreased 2 0
3.Other Pre-specified Outcome
Title Progression-free Survival
Hide Description From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients.
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description:
Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 62 58
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.8 to 2.9)
1.9
(1.8 to 2.1)
4.Other Pre-specified Outcome
Title Objective Response Rate
Hide Description Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and analyzable patients with measurable disease.
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description:
Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 57 55
Measure Type: Number
Unit of Measure: participants
Partial Response 4 0
Unconfirmed Partial Response 1 1
Stable/No response 14 12
Increasing disease 29 34
Symptomatic Deterioration 3 2
Assessment Inadequate 6 6
Time Frame Up to 3 years
Adverse Event Reporting Description Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
 
Arm/Group Title mFOLFOX MK2206 and Selumetinib
Hide Arm/Group Description Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
mFOLFOX MK2206 and Selumetinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
mFOLFOX MK2206 and Selumetinib
Affected / at Risk (%) Affected / at Risk (%)
Total   2/62 (3.23%)   37/57 (64.91%) 
Blood and lymphatic system disorders     
Anemia   0/62 (0.00%)  2/57 (3.51%) 
Cardiac disorders     
Left ventricular systolic dysfunction   0/62 (0.00%)  1/57 (1.75%) 
Myocardial infarction   0/62 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Abdominal distension   0/62 (0.00%)  1/57 (1.75%) 
Abdominal pain   0/62 (0.00%)  1/57 (1.75%) 
Colonic perforation   1/62 (1.61%)  0/57 (0.00%) 
Constipation   0/62 (0.00%)  2/57 (3.51%) 
Diarrhea   0/62 (0.00%)  3/57 (5.26%) 
Duodenal perforation   0/62 (0.00%)  1/57 (1.75%) 
Dysphagia   0/62 (0.00%)  1/57 (1.75%) 
Gastric perforation   0/62 (0.00%)  1/57 (1.75%) 
Mucositis oral   0/62 (0.00%)  2/57 (3.51%) 
Nausea   0/62 (0.00%)  1/57 (1.75%) 
Vomiting   0/62 (0.00%)  2/57 (3.51%) 
General disorders     
Fatigue   0/62 (0.00%)  2/57 (3.51%) 
Fever   0/62 (0.00%)  2/57 (3.51%) 
General disorders and admin site conditions - Other   0/62 (0.00%)  1/57 (1.75%) 
Multi-organ failure   0/62 (0.00%)  1/57 (1.75%) 
Hepatobiliary disorders     
Hepatic failure   0/62 (0.00%)  1/57 (1.75%) 
Infections and infestations     
Infections and infestations-Other   0/62 (0.00%)  2/57 (3.51%) 
Lung infection   1/62 (1.61%)  1/57 (1.75%) 
Sepsis   1/62 (1.61%)  2/57 (3.51%) 
Skin infection   0/62 (0.00%)  1/57 (1.75%) 
Soft tissue infection   0/62 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications     
Intraoperative gastrointestinal injury   0/62 (0.00%)  1/57 (1.75%) 
Spinal fracture   0/62 (0.00%)  1/57 (1.75%) 
Investigations     
Alanine aminotransferase increased   0/62 (0.00%)  1/57 (1.75%) 
Alkaline phosphatase increased   0/62 (0.00%)  2/57 (3.51%) 
Aspartate aminotransferase increased   0/62 (0.00%)  1/57 (1.75%) 
Blood bilirubin increased   0/62 (0.00%)  2/57 (3.51%) 
Investigations-Other   0/62 (0.00%)  1/57 (1.75%) 
Metabolism and nutrition disorders     
Anorexia   0/62 (0.00%)  2/57 (3.51%) 
Dehydration   0/62 (0.00%)  7/57 (12.28%) 
Hyperglycemia   0/62 (0.00%)  5/57 (8.77%) 
Hyponatremia   0/62 (0.00%)  2/57 (3.51%) 
Hypophosphatemia   0/62 (0.00%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Back pain   0/62 (0.00%)  1/57 (1.75%) 
Generalized muscle weakness   0/62 (0.00%)  3/57 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   0/62 (0.00%)  10/57 (17.54%) 
Nervous system disorders     
Cognitive disturbance   0/62 (0.00%)  1/57 (1.75%) 
Depressed level of consciousness   0/62 (0.00%)  1/57 (1.75%) 
Encephalopathy   0/62 (0.00%)  1/57 (1.75%) 
Stroke   0/62 (0.00%)  1/57 (1.75%) 
Syncope   0/62 (0.00%)  2/57 (3.51%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis   0/62 (0.00%)  1/57 (1.75%) 
Hypoxia   0/62 (0.00%)  1/57 (1.75%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme   0/62 (0.00%)  1/57 (1.75%) 
Erythroderma   0/62 (0.00%)  1/57 (1.75%) 
Rash acneiform   0/62 (0.00%)  2/57 (3.51%) 
Rash maculo-papular   0/62 (0.00%)  4/57 (7.02%) 
Stevens-Johnson syndrome   0/62 (0.00%)  1/57 (1.75%) 
Vascular disorders     
Hypertension   0/62 (0.00%)  4/57 (7.02%) 
Hypotension   0/62 (0.00%)  2/57 (3.51%) 
Thromboembolic event   0/62 (0.00%)  3/57 (5.26%) 
Visceral arterial ischemia   1/62 (1.61%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
mFOLFOX MK2206 and Selumetinib
Affected / at Risk (%) Affected / at Risk (%)
Total   56/62 (90.32%)   53/57 (92.98%) 
Blood and lymphatic system disorders     
Anemia   26/62 (41.94%)  17/57 (29.82%) 
Gastrointestinal disorders     
Abdominal distension   0/62 (0.00%)  3/57 (5.26%) 
Abdominal pain   26/62 (41.94%)  14/57 (24.56%) 
Ascites   1/62 (1.61%)  3/57 (5.26%) 
Bloating   5/62 (8.06%)  2/57 (3.51%) 
Constipation   25/62 (40.32%)  8/57 (14.04%) 
Diarrhea   23/62 (37.10%)  17/57 (29.82%) 
Dry mouth   0/62 (0.00%)  7/57 (12.28%) 
Dyspepsia   4/62 (6.45%)  4/57 (7.02%) 
Flatulence   1/62 (1.61%)  4/57 (7.02%) 
Mucositis oral   8/62 (12.90%)  12/57 (21.05%) 
Nausea   39/62 (62.90%)  25/57 (43.86%) 
Vomiting   21/62 (33.87%)  21/57 (36.84%) 
General disorders     
Chills   2/62 (3.23%)  10/57 (17.54%) 
Edema face   0/62 (0.00%)  6/57 (10.53%) 
Edema limbs   6/62 (9.68%)  9/57 (15.79%) 
Fatigue   39/62 (62.90%)  25/57 (43.86%) 
Fever   4/62 (6.45%)  6/57 (10.53%) 
Pain   4/62 (6.45%)  0/57 (0.00%) 
Infections and infestations     
Infections and infestations-Other   1/62 (1.61%)  6/57 (10.53%) 
Investigations     
Alanine aminotransferase increased   9/62 (14.52%)  17/57 (29.82%) 
Alkaline phosphatase increased   18/62 (29.03%)  13/57 (22.81%) 
Aspartate aminotransferase increased   13/62 (20.97%)  20/57 (35.09%) 
Blood bilirubin increased   5/62 (8.06%)  3/57 (5.26%) 
Creatinine increased   3/62 (4.84%)  9/57 (15.79%) 
Investigations-Other   4/62 (6.45%)  4/57 (7.02%) 
Lymphocyte count decreased   15/62 (24.19%)  8/57 (14.04%) 
Neutrophil count decreased   12/62 (19.35%)  1/57 (1.75%) 
Platelet count decreased   21/62 (33.87%)  6/57 (10.53%) 
Weight loss   13/62 (20.97%)  6/57 (10.53%) 
White blood cell decreased   13/62 (20.97%)  1/57 (1.75%) 
Metabolism and nutrition disorders     
Anorexia   25/62 (40.32%)  20/57 (35.09%) 
Dehydration   7/62 (11.29%)  6/57 (10.53%) 
Hyperglycemia   20/62 (32.26%)  22/57 (38.60%) 
Hypoalbuminemia   20/62 (32.26%)  17/57 (29.82%) 
Hypocalcemia   9/62 (14.52%)  7/57 (12.28%) 
Hypokalemia   11/62 (17.74%)  4/57 (7.02%) 
Hypomagnesemia   5/62 (8.06%)  2/57 (3.51%) 
Hyponatremia   10/62 (16.13%)  15/57 (26.32%) 
Musculoskeletal and connective tissue disorders     
Back pain   10/62 (16.13%)  3/57 (5.26%) 
Generalized muscle weakness   4/62 (6.45%)  6/57 (10.53%) 
Nervous system disorders     
Dizziness   4/62 (6.45%)  10/57 (17.54%) 
Dysgeusia   8/62 (12.90%)  8/57 (14.04%) 
Headache   6/62 (9.68%)  2/57 (3.51%) 
Paresthesia   7/62 (11.29%)  0/57 (0.00%) 
Peripheral sensory neuropathy   29/62 (46.77%)  4/57 (7.02%) 
Psychiatric disorders     
Anxiety   5/62 (8.06%)  4/57 (7.02%) 
Depression   4/62 (6.45%)  4/57 (7.02%) 
Insomnia   8/62 (12.90%)  4/57 (7.02%) 
Respiratory, thoracic and mediastinal disorders     
Cough   11/62 (17.74%)  2/57 (3.51%) 
Dyspnea   6/62 (9.68%)  7/57 (12.28%) 
Pleural effusion   1/62 (1.61%)  3/57 (5.26%) 
Skin and subcutaneous tissue disorders     
Alopecia   12/62 (19.35%)  0/57 (0.00%) 
Dry skin   6/62 (9.68%)  5/57 (8.77%) 
Pruritus   2/62 (3.23%)  8/57 (14.04%) 
Rash acneiform   0/62 (0.00%)  9/57 (15.79%) 
Rash maculo-papular   3/62 (4.84%)  18/57 (31.58%) 
Skin and subcutaneous tissue disorders - Other   1/62 (1.61%)  3/57 (5.26%) 
Vascular disorders     
Hypertension   8/62 (12.90%)  7/57 (12.28%) 
Hypotension   3/62 (4.84%)  4/57 (7.02%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SWOG Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4408
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01658943     History of Changes
Other Study ID Numbers: NCI-2012-01993
NCI-2012-01993 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S1115
CDR0000737878
S1115 ( Other Identifier: SWOG )
S1115 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2012
First Posted: August 7, 2012
Results First Submitted: February 10, 2016
Results First Posted: March 9, 2016
Last Update Posted: March 9, 2016