Trial record 1 of 1 for:    NCT00866333
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A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00866333
First received: March 19, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Syndax Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response based on the patient's best overall response that is documented throughout the entire course of protocol therapy [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Duration of response for patients achieving CR or PR [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Examine the safety profile of entinostat [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866333

Locations
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
  More Information

No publications provided

Responsible Party: Syndax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00866333     History of Changes
Other Study ID Numbers: SNDX-275-0501
Study First Received: March 19, 2009
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014