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A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866333
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Brief Summary:
This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with relapsed or refractory Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: entinostat (SNDX-275) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study Start Date : March 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: treatment
entinostat, oral, once weekly for 3 weeks followed by a 1-week break in a 4-week cycle
Drug: entinostat (SNDX-275)
entinostat, oral, once weekly for 3 weeks followed by a 1-week break in a 4-week cycle

Primary Outcome Measures :
  1. Objective response (CR or PR) based on the patient's best response that is documented within the first 6 cycles of protocol therapy. Response will be assessed based on the revised criteria for malignant lymphoma (Cheson 2007) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Objective response based on the patient's best overall response that is documented throughout the entire course of protocol therapy [ Time Frame: ongoing ]
  2. Duration of response for patients achieving CR or PR [ Time Frame: ongoing ]
  3. Examine the safety profile of entinostat [ Time Frame: ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Pathologic confirmation of relapsed or refractory classical Hodgkin's lymphoma from the last biopsy available. Relapsed disease is defined as progressive disease following systematic therapy(ies) with curative intent. Refractory disease is defined as disease not responding to or having progressed within 3 months of the last dose of most recent systemic therapy
  2. Must have progressed after, or been ineligible for, stem cell transplantation
  3. Documented disease that is radiographically measurable (≥ 1.5 cm in the largest transverse dimension). If only 1 site of radiographically measurable lesion with the longest diameter < 2.5 cm, lesion must be positive by FDG-PET or biopsy.
  4. Last dose of cytotoxic chemotherapy must be > 21 days before the first dose of study drug.
  5. ECOG performance status of 0 or 1
  6. Age 18 years or older
  7. Total Bilirubin ≤ 1.5 x ULN and AST and ALT ≤ 2.5 x ULN, possible exceptions if documented HL liver involvement.
  8. Serum Creatinine ≤ 1.5 x ULN
  9. Absolute neutrophil counts of ≥ 1,000/µL, and platelet counts ≥ 50,000/µL
  10. Patients or their legal representative must be able to read, understand, and sign a written informed consent

Exclusion Criteria:

  1. Patients with another active cancer (excluding basal cell carcinoma or CIN/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, excluding active disease within the prior 5 years.
  2. Prior allogeneic stem cell transplantation requiring active immunosuppressive therapy within 3 months of registration or with evidence of active GVHD.
  3. Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test prior to start of study drug.
  4. WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following the last dose of study drug.
  5. Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5⁰C that has not been evaluated for infection on the day of scheduled dosing.
  6. Patients who have been treated with any investigational drug within 28 days prior to the first dose of study medication, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
  7. Prior treatment with HDAC inhibitors (e.g. valproic acid, Zolinza (SAHA), romidepsin (Istodax),and experimental compounds such as MethylGene's MCGD0103 and Novartis' LBH589)
  8. History of pericarditis or pericardial effusion that had required medical or surgical intervention in the last 6 months, or myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease or a QTc interval >0.47 seconds
  9. Known HIV or a history of active Hepatitis B or C as evidenced by laboratory abnormalities in addition to positive serology.
  10. Active central nervous system lymphoma and lymphoma with leptomeningeal involvement
  11. Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and comply with study procedures
  12. Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures
  13. History of gastrointestinal disorders (medical disorder or extensive surgery) that could interfere with absorption of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866333

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United States, California
Tower Cancer Research Foundaton
Beverly Hills, California, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Syndax Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Syndax Pharmaceuticals Identifier: NCT00866333     History of Changes
Other Study ID Numbers: SNDX-275-0501
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Keywords provided by Syndax Pharmaceuticals:
Hodgkin's Lymphoma
Relapsed Hodgkin's Lymphoma
Refractory Hodgkin's Lymphoma

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action