Know Cancer

forgot password

A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

Phase 2
18 Years
Not Enrolling
Hodgkin Lymphoma

Thank you

Trial Information

A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Response Using Cheson Criteria

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Mayo Clinic Rochester, Minnesota  55905
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Nebraska Medical Center Omaha, Nebraska  68198
UCLA Jonsson Comprehensive Cancer Center Los Angeles, California  90095
Northwestern University, The Robert H Lurie Comprehensive Cancer Center Chicago, Illinois  60611