Clinical trial · Interventional
Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
Phase II Study of MK-2206 in Patients With Relapsed Lymphoma
NCT01258998CI-TRIAL-00048080completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (36)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Nasal Type Extranodal NK/T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| B-cell Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Akt inhibitor MK2206 | Drug | Akt Inhibitor MK2206 | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Akt inhibitor MK2206)
- description
- Patients 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.
- interventionNames
- Drug: Akt inhibitor MK2206
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 4 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Significant heart block or baseline bradycardia \< 50 beats per minute (bpm) due to cardiac disease * Patients who are pregnant or breastfeeding
References
Publications (1)
- DERIVEDOki 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 26213141