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
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Tracking Information | ||||
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First Submitted Date ICMJE | August 3, 2012 | |||
First Posted Date ICMJE | August 7, 2012 | |||
Results First Submitted Date ICMJE | February 10, 2016 | |||
Results First Posted Date ICMJE | March 9, 2016 | |||
Last Update Posted Date | March 9, 2016 | |||
Study Start Date ICMJE | August 2012 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Up to 3 years ] 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.
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ] Only adverse events that are possibly, probably or definitely related to study drug are reported.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy | |||
Official Title ICMJE | Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients With Metastatic Pancreatic Cancer After Prior Chemotherapy | |||
Brief Summary | This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in treating patients with metastatic pancreatic cancer previously treated with chemotherapy. Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients with metastatic pancreatic cancer. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate (selumetinib) and MK-2206 (Akt inhibitor MK2206) compared to those treated with mFOLFOX. SECONDARY OBJECTIVES: I. To assess the frequency and severity of toxicity associated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those with mFOLFOX in this patient population. TERTIARY OBJECTIVES: I. To assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. II. To assess objective tumor response in the subset of patients with measurable disease (confirmed and unconfirmed complete and partial response) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. III. To bank tissue and blood for future translational medicine studies. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16 (mFOLFOX). ARM II: Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28. In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Chung V, McDonough S, Philip PA, Cardin D, Wang-Gillam A, Hui L, Tejani MA, Seery TE, Dy IA, Al Baghdadi T, Hendifar AE, Doyle LA, Lowy AM, Guthrie KA, Blanke CD, Hochster HS. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial. JAMA Oncol. 2017 Apr 1;3(4):516-522. doi: 10.1001/jamaoncol.2016.5383. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
137 | |||
Original Estimated Enrollment ICMJE |
133 | |||
Actual Study Completion Date ICMJE | June 2015 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01658943 | |||
Other Study ID Numbers ICMJE | 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 ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | National Cancer Institute (NCI) | |||
Original Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | |||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Original Study Sponsor ICMJE | SWOG Cancer Research Network | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | July 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |