MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery
A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers
7 other identifiers
interventional
8
1 country
8
Brief Summary
This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2011
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 27, 2011
CompletedFirst Posted
Study publicly available on registry
August 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
April 15, 2016
CompletedJune 17, 2016
May 1, 2016
2.1 years
August 27, 2011
March 15, 2016
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year
Secondary Outcomes (3)
Frequency of Adverse Events Related to MK-2206
Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year
Overall Survival
From study initiation to time of death, assessed up to 4 weeks after completion of study treatment
Progression-free Survival
From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment
Study Arms (1)
Treatment (Akt inhibitor MK2206)
EXPERIMENTALPatients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed biliary tract carcinoma that is surgically unresectable
- Cytological confirmation is not allowed on this study, as tissue is needed for correlative science analysis
- Either fresh-frozen tissue (FFT) or paraffin-embedded tissue blocks (PETB) will be required from patients before enrolling on this study
- No biopsies will be required unless there is insufficient tissue or if the PETB available is more than 12 months old
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan (CT scan slice thickness no greater than 5 mm)
- Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis
- Patients must have received one prior therapy for metastatic disease
- No prior Akt inhibitors allowed
- Patients with known brain metastases should be excluded from this clinical trial
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\<2 (Karnofsky \>= 60%)
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelet count \>= 100,000/mcL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tanios Bekaii-Saab, MD
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Tanios Bekaii-Saab
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2011
First Posted
August 30, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2014
Last Updated
June 17, 2016
Results First Posted
April 15, 2016
Record last verified: 2016-05