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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01658943
First received: August 3, 2012
Last updated: February 10, 2016
Last verified: July 2015
Results First Received: February 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
mFOLFOX 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.
MK2206 and Selumetinib 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.

Participant Flow:   Overall Study
    mFOLFOX     MK2206 and Selumetinib  
STARTED     70     67  
Eligible     63     58  
Eligible and Began Protocol Therapy     62     58  
COMPLETED     0     0  
NOT COMPLETED     70     67  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible and analyzable patients.

Reporting Groups
  Description
mFOLFOX 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.
MK2206 and Selumetinib 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 Total of all reporting groups

Baseline Measures
    mFOLFOX     MK2206 and Selumetinib     Total  
Number of Participants  
[units: participants]
  62     58     120  
Age  
[units: years]
Median (Full Range)
  65.6  
  (34.2 to 82.8)  
  69.4  
  (54.2 to 88.0)  
  67.3  
  (34.2 to 88.0)  
Gender  
[units: participants]
     
Female     40     23     63  
Male     22     35     57  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     1     4  
Not Hispanic or Latino     59     57     116  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     4     8  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     7     4     11  
White     50     49     99  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Prior Systemic Therapy  
[units: participants]
     
4 months or less     23     22     45  
more than 4 months     39     36     75  
Liver Metastasis  
[units: participants]
     
Yes     39     43     82  
No     23     15     38  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Up to 3 years ]

2.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 3 years ]

3.  Other Pre-specified:   Progression-free Survival   [ Time Frame: Up to 3 years ]

4.  Other Pre-specified:   Objective Response Rate   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: SWOG Statistician
Organization: SWOG Statistical Center
phone: 206-667-4408



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 ( US NIH Grant/Contract Award Number )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: August 3, 2012
Results First Received: February 10, 2016
Last Updated: February 10, 2016
Health Authority: United States: Food and Drug Administration