Study of MK-2206 in Patients With Relapsed Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01258998
First received: December 10, 2010
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
The goal of this clinical research study is to learn if MK-2206 can help to control Hodgkin and non-Hodgkin lymphoma. The safety of this drug will also be studied
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: Akt inhibitor MK2206 Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of MK-2206 in Patients With Relapsed Lymphoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- ORR [ Time Frame: 4 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
- Duration of response [ Time Frame: From the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
- Overall survival [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
- Toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated. No formal statistical testing will be performed on these summary data.
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (Akt inhibitor MK2206)
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.
|
Drug: Akt inhibitor MK2206
Given PO
Other Name: MK2206
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the objective response rate (ORR) of MK-2206 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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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 ULN for patients with liver involvement)
- AST, ALT > 2.5 x ULN (> 5 x ULN for patients with liver involvement)
- Serum creatinine > 2 x ULN
- HbA1C > 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01258998 History of Changes |
| Other Study ID Numbers: | NCI-2012-02890, 2010-0261, N01CM00039 |
| Study First Received: | December 10, 2010 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Mycoses Mycosis Fungoides Sezary Syndrome |
Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
ClinicalTrials.gov processed this record on May 19, 2013