Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Diffuse Large B Cell Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer c...

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective response rate (ORR) at 4 months (complete response \[CR\], and partial response \[PR\]...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed diffuse large B-cell lymphoma
  • Relapsed or refractory disease
  • Measurable disease
  • At least one measurable lymph node mass that is \> 1.5 cm in two perpendicular dimensions and that has not been previously irradiated or has grown since previous irradiation
  • Dominant lymph node masses include up to 6 nodal masses that are clearly measurable in 2 perpendicular dimensions and \> 1.5 cm in each dimension
  • Measurement may be by radiographic imaging
  • If there are lymph node masses in the mediastinum or pelvis larger than 1.5 cm in 2 perpendicular dimensions, they should always be chosen as dominant masses
  • The dominant masses should be from as disparate regions of the body as possible
  • Measurable sites of disease are also extra-nodal sites such as splenic nodules and hepatic nodules that are thought to contain lymphoma, and are greater than 1 cm in the longest transverse dimension
  • Must have received at least two prior treatment lines; there is no maximal limit on the number of prior therapies
  • Prior treatment must include CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)-like chemotherapy in combination with rituximab
  • Rituximab used alone is not considered as a separate regimen
  • Salvage treatment, mobilization chemotherapy, high-dose chemotherapy, and planned post-transplant therapy should be considered as one regimen
  • Relapsed or refractory patients who are candidates for high-dose chemotherapy and autologous or allogeneic stem cell transplantation are not eligible
  • Tumor tissue sample must be available for pathological review
  • No known CNS involvement
  • ECOG performance status \< 2 (Karnofsky \> 60%)
  • Life expectancy \> 4 months
  • Absolute neutrophil count \>= 1,500/µL
  • Platelets \>= 100,000/µL (\>= 75,000/µL if the bone marrow is involved)
  • Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) =\< 2.5 X ULN
  • Calculated creatinine clearance \>= 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of child-bearing potential and men must agree to use adequate contraception
  • Must be able to swallow whole tablets
  • Nasogastric or G-tube administration is not allowed
  • Tablets must not be crushed or chewed
  • Patients with French Social Security in compliance with the French law relating to biomedical research allowed
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK2206 tablets
  • Hyperglycemia should be well controlled on oral agents
  • Cardiovascular baseline QTcF =\< 450 msec (male) or QTcF =\< 470 msec (female)
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No HIV-positive patients on combination antiretroviral therapy
  • No patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
  • No patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis
  • No prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \>= 3 years
  • Must have recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients must have discontinued all prior therapies for at least 5 times the half-life of all prior anticancer therapies before study entry
  • Prior treatment could include high-dose chemotherapy with autologous stem-cell transplantation if patients had progressed \>= 3 months after this treatment
  • No chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
  • Patients must not be receiving any other investigational agents
  • No other investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
  • No concurrent radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    December 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2014

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT01481129

    Start Date

    December 1 2011

    End Date

    June 1 2014

    Last Update

    September 28 2017

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Hopitaux de Paris

    Vellefaux, Paris, France, 75010

    2

    Institut Bergonie Cancer Center

    Bordeaux, France, 33076

    3

    Henri Mondor University-Hospital Center

    Créteil, France, 94000

    4

    Hospital Claude Huriez Chru

    Lille, France, 59037