Clinical trial NCT01217229: Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Official title: A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Plexxikon
First posted: 2010-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 graft versus host disease (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 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. 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 Transaminase (AST) / Alanine Transaminase (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

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. Corrected QT interval (QTc) ≥450 msec.

Primary outcomes:
measure: Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
timeFrame: Baseline to 1 year postdose
measure: Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
timeFrame: Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose
measure: Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
timeFrame: Baseline to 1 year post-dose
measure: Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
timeFrame: Baseline to 1 year postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: Northwestern University, The Robert H Lurie Comprehensive Cancer Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: