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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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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 ]

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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 ]

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3. Other Pre-specified:

Progression-free Survival [ Time Frame: Up to 3 years ]

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4. Other Pre-specified:

Objective Response Rate [ Time Frame: Up to 3 years ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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

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