Phase 2
Completed N=60
Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
Source: ClinicalTrials.gov NCT01258998 ↗Enrolled (actual)
60
Serious AEs
8.3%
Results posted
Nov 2015
Primary outcomePrimary: Objective Response Rate (ORR) — 2; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
2; 6 | — |
| SECONDARY Progression-free Survival |
2.8 | — |
| SECONDARY Duration of Response |
5.8 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Number of Participants With Change in Cytokine Levels With p Values <0.05 |
36 | — |
| SECONDARY Number of Participants With Change in Chemokine Levels With p Values <0.05 |
— | — |
| SECONDARY Number of Participants With Change in Biomarker Levels With p Values <0.05 |
— | — |
| SECONDARY Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
12; 4; 4; 3; 4; 9 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01258998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.