A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Michelle A. Fanale
The main goal of this clinical research study is to learn if the study drug PLX3397 can help to control Hodgkin lymphoma. The safety of this study drug and how the study drug affects your body will also be studied.
Disease Group: Lymphoma
Treatment Agent: PLX3397
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: Plexxikon Inc.
Primary 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 Hodgkins Lymphoma (HL). Secondary Secondary objectives include safety, the duration of response, the percentage of patients benefiting from PLX3397 complete response+ partial response+ stable disease(CR+PR+SD), Progression Free Survival (PFS), and PD biomarkers.
IRB Review and Approval Date: 01/07/2011
Recruitment Status: Not Accepting
Projected Accrual: 30
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 transplant are eligible if they have no evidence of GVHD and have been off immunosuppression for at least 3 months prior to cycle 1 day 1 (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 Cycle1Day 1 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) Eastern Cooperative Oncology Group (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, Aspartate aminotransferase/Alanine aminotransferase (AST/ALT) </=2.5x Upper limit of normal (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
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 Cycle1Day1
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) QT interval corrected (QTc) >/= 450 msec
Information and next steps
Michelle A. Fanale
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