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Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin 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: NCT01217229
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : March 15, 2013
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):

Brief Summary:
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: PLX3397 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Study Start Date : December 2010
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PLX3397 Drug: PLX3397
Capsules administered once or twice daily, continuous dosing. Subjects will begin with 900 mg/day, but should safety data allow in our PLX108-01 study, subject may dose at 1200 mg/day.

Primary Outcome Measures :
  1. Disease Response Using Cheson Criteria [ Time Frame: 1 year ]
    Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 Year ]
    Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.

  2. Pharmacodynamic Biomarkers [ Time Frame: 1 year ]
    Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.

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. Male or female patients ≥18 years old
  2. Pathologic confirmation of relapsed or refractory classical Hodgkin lymphoma, with archival or fresh tissue available for retrospective analysis.
  3. Patients must have progressed after-or been ineligible for-autologous stem cell transplantation. Patients who received a prior allogeneic stem cell transplantation are eligible if they have no evidence of GVHD and have been off immunosuppression for at least 3 months prior to C1D1.
  4. Documented disease that is radiographically measurable (≥2 cm in the largest transverse dimension).
  5. Patients must have discontinued any previous monoclonal antibody, radioimmunotherapy, or cytotoxic chemotherapy at least 28 days prior to C1D1 and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
  6. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.
  7. ECOG performance status 0 or 1
  8. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN)
  9. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion Criteria:

  1. Investigational drug use within 28 days of the first dose of PLX3397
  2. History or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
  3. Patients with another active cancer [excluding basal cell carcinoma or cervical intraepithelial neoplasia (cervical carcinoma in situ) or melanoma in situ]. Prior history of other cancer is allowed, as long as there was no active disease within the prior 5 years.
  4. Patients with uncontrolled intercurrent illness, an active or uncontrolled infection, or a fever >38.5˚C (not due to tumor fever) on C1D1
  5. Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
  6. Patients with serious illnesses, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
  7. Women of child-bearing potential who are pregnant or breast feeding
  8. QTc ≥450 msec

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): NCT01217229

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United States, California
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
United States, Illinois
Northwestern University, The Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators

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Responsible Party: Plexxikon Identifier: NCT01217229     History of Changes
Other Study ID Numbers: PLX108-03
First Posted: October 8, 2010    Key Record Dates
Results First Posted: March 15, 2013
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Plexxikon:
Hodgkin Lymphoma

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