Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
Phase II Study of MK-2206 in Patients With Relapsed Lymphoma
7 other identifiers
interventional
60
1 country
1
Brief Summary
This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 10, 2010
CompletedFirst Posted
Study publicly available on registry
December 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 10, 2015
CompletedNovember 4, 2020
October 1, 2020
3.6 years
December 10, 2010
October 9, 2015
October 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regression of measurable disease and no new sites, 50% decrease in , sum of the product of the diameters SPD of up to 6 largest dominant masses; no increase in size of other nodes(a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT, 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen, Irrelevant if positive prior to therapy; cell type should be specified.
4 months
Secondary Outcomes (7)
Progression-free Survival
From treatment start date until the date of first documented progression or date of death from any cause, whichever came first.
Duration of Response
From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Overall Survival
From the start of treatment to death or 30 days after removal from the study whichever occurs first
Number of Participants With Change in Cytokine Levels With p Values <0.05
Baseline to up to 30 days post-treatment
Number of Participants With Change in Chemokine Levels With p Values <0.05
Baseline to up to 30 days post-treatment
- +2 more secondary outcomes
Study Arms (1)
Treatment (Akt inhibitor MK2206)
EXPERIMENTALPatients receive Akt inhibitor MK2206 PO once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma may be included)
- Relapsed or refractory after at least one regimen and with no curative option with conventional therapy
- Bidimensionally measurable disease (at least 2 cm)
- No evidence of cerebral or meningeal involvement by lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Signed informed consent form prior to enrollment
- Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately
You may not qualify if:
- Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia and cutaneous T-cell lymphoma
- Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior to entering the study unless there is clear evidence of progression of disease and toxicity from previous treatment has resolved in which case study entry may be within 1 week of last treatment
- Previous radioimmunotherapy within 12 weeks
- Patients with known immunodeficiency virus (HIV) infection must not have cluster of differentiation (CD)4 cells \< 400/mm\^3 and who must not have a prior acquired immunodeficiency syndrome (AIDS)-defining diagnosis and cannot be on antiretroviral therapy for HIV
- Known active viral hepatitis
- Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or with compliance with the study
- Absolute neutrophil count \< 1.5 x 10\^9/L
- Platelets \< 75 x 10\^9/L
- Total bilirubin \> 1.5 x upper limit of normal (ULN) (\> 3 x ULN for patients with liver involvement)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 2.5 x ULN (\> 5 x ULN for patients with liver involvement)
- Serum creatinine \> 2 x ULN
- Hemoglobin (Hb)A1C \> 8%
- Patients receiving any medications or substances that are inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible
- Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
- Cardiovascular: baseline Fredericia corrected QT interval (QTcF) \> 450 msec (male) or QTcF \> 470 msec (female) will exclude patients from entry on study
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Oki Y, Fanale M, Romaguera J, Fayad L, Fowler N, Copeland A, Samaniego F, Kwak LW, Neelapu S, Wang M, Feng L, Younes A. Phase II study of an AKT inhibitor MK2206 in patients with relapsed or refractory lymphoma. Br J Haematol. 2015 Nov;171(4):463-70. doi: 10.1111/bjh.13603. Epub 2015 Jul 27.
PMID: 26213141DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher R Flowers,Chair, Lymphoma-Myeloma
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yasuhiro Oki
M.D. Anderson 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
December 10, 2010
First Posted
December 13, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2014
Study Completion
August 1, 2015
Last Updated
November 4, 2020
Results First Posted
November 10, 2015
Record last verified: 2020-10