Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
|Diffuse Large B Cell Lymphoma||Drug: Akt Inhibitor MK2206 Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of MK-2206 in Patients With Relapsed or Refractory Diffuse Large-B Cell Lymphoma|
- Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007) [ Time Frame: Up to 4 months ]Relying on a two-stage Simon's design.
- Duration of Response [ Time Frame: up to 4 years ]Described in responding subjects using descriptive statistics (median, extreme values, etc.).
- Overall Survival [ Time Frame: From the date of inclusion to the date of death from any cause, assessed up to 4 years ]Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
- Progression-free Survival (PFS) [ Time Frame: From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years ]Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
- Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 30 days ]
|Actual Study Start Date:||December 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt Inhibitor MK2206
Other Name: MK2206Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
I. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective response rate (ORR) at 4 months (complete response [CR], and partial response [PR]) as per the 2007 International Cheson response criteria.
I. To evaluate the antitumor activity of MK2206 in terms of ORR at 4 months (CR, unconfirmed complete response [CRu], and PR) as per the 1999 International Cheson response criteria.
II. To determine the duration of response, defined as the time from the date of the best response to the date of progression.
III. To determine the progression-free survival and overall survival of these patients.
IV. To determine the safety of MK2206. V. To identify predictive biomarkers for treatment outcome. (exploratory) VI. To conduct a pharmacodynamic study using FDG-PET scans. (exploratory)
OUTLINE: This a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481129
|Hopitaux de Paris|
|Vellefaux, Paris, France, 75010|
|Institut Bergonie Cancer Center|
|Bordeaux, France, 33076|
|Henri Mondor University-Hospital Center|
|Creteil, France, 94000|
|Hospital Claude Huriez Chru|
|Lille, France, 59037|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|Hopital Saint Louis|
|Paris, France, 75010|
|Centre Hospitalier Lyon-Sud|
|Pierre Benite, France, 69310|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Principal Investigator:||Herve Ghesquieres||Centre Leon Berard|