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PHASE II STUDY OF MK-2206 IN PATIENTS WITH RELAPSED LYMPHOMA


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia

Thank you

Trial Information

PHASE II STUDY OF MK-2206 IN PATIENTS WITH RELAPSED LYMPHOMA


PRIMARY OBJECTIVES:

I. Determine the objective response rate (ORR) of MK-2206 (Akt inhibitor MK2206) in patients
with relapsed/refractory lymphoma.

SECONDARY OBJECTIVES:

I. Assess the progression free survival (PFS) of MK-2206 in patients with
relapsed/refractory lymphoma II. Assess the safety and tolerability of MK-2206 monotherapy
III. Examine pretreatment pAkt protein expression by immunohistochemistry, and correlate the
results with treatment response.

IV. Examine the effect of therapy on serum cytokines and chemokines that regulate the
tumor-promoting inflammatory process and/or immunity in patients with relapsed/refractory
lymphoma, and correlate the results with treatment response.

OUTLINE:

Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Treatment repeats every 28
days for up to 12 courses in the absence of disease progression or unacceptable toxicity.


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 HIV infection must not have CD4 cells < 400/mm3 and who must not
have a prior 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 ULN (> 3 x upper limit of normal [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 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 QTcF > 450 msec (male) or QTcF > 470 msec (female) will
exclude patients from entry on study

- Significant heart block or baseline bradycardia < 50bpm due to cardiac disease

- Patients who are pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ORR

Outcome Description:

Objective response (OR) rate along with its 95% confidence interval (CI) will be estimated for each patient cohort. Logistic regression will be utilized to assess the effect of patient demographic factors on OR.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Yasuhiro Oki

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02890

NCT ID:

NCT01258998

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Adult Grade III Lymphomatoid Granulomatosis
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncutaneous Extranodal Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Hairy Cell Leukemia
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Hairy Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell
  • Leukemia, Large Granular Lymphocytic

Name

Location
M D Anderson Cancer Center Houston, Texas  77030