Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

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.

PLX3397

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.

Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

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

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).

Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response 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.

Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).

Plexxikon

Daiichi Sankyo

Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Medical Director

Progression-free survival was assessed in the Modified Intent-to-Treat population.

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)

Overall: Target tumor response (CR+PR)

Overall: Target tumor DCR (CR+PR+SD)

Overall: Complete response (CR)

Overall: Partial response (PR)

Overall: Stable disease (SD)

Overall: Relapsed disease or progressive disease

Cycle 3: Target tumor response (CR+PR)

Cycle 3: Target tumor DCR (CR+PR+SD)

Cycle 3: Complete response (CR)

Cycle 3: Partial response (PR)

Cycle 3: Stable disease (SD)

Cycle 3: Relapsed disease or progressive disease

Cycle 5: Target tumor response (CR+PR)

Cycle 5: Target tumor DCR (CR+PR+SD)

Cycle 5: Complete response (CR)

Cycle 5: Partial response (PR)

Cycle 5: Stable disease (SD)

Cycle 5: Relapsed disease or progressive disease

Cycle 7: Target tumor response (CR+PR)

Cycle 7: Target tumor DCR (CR+PR+SD)

Cycle 7: Complete response (CR)

Cycle 7: Partial response (PR)

Cycle 7: Stable disease (SD)

Cycle 7: Relapsed disease or progressive disease

Cycle 10: Target tumor response (CR+PR)

Cycle 10: Target tumor DCR (CR+PR+SD)

Cycle 10: Complete response (CR)

Cycle 10: Partial response (PR)

Cycle 10: Stable disease (SD)

Cycle 10: Relapsed disease or progressive disease

Cycle 13: Target tumor response (CR+PR)

Cycle 13: Target tumor DCR (CR+PR+SD)

Cycle 13: Complete response (CR)

Cycle 13: Partial response (PR)

Cycle 13: Stable disease (SD)

Cycle 13: Relapsed disease or progressive disease

Tumor response was assessed in the Modified Intent-to-Treat population.

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)

At least 1 adverse event

Anaemia

Thrombocytopenia

Diarrhoea

Nausea

Vomiting

Chills

Fatigue

Pyrexia

Aspartate aminotransferase increased

Blood lactate dehydrogenase increased

Decreased appetite

Back pain

Dizziness

Headache

Cough

Dyspnoea

Productive cough

Hair colour changes

Rash

Adverse events were assessed in the Safety Analysis population.

Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)

At least 1 Grade 2 adverse event

At least 1 Grade 3 adverse event

Grade 2 Anaemia

Grade 2 Neutropenia

Grade 3 Neutropenia

Grade 2 Thrombocytopenia

Grade 3 Thrombocytopenia

Grade 2 Fatigue

Grade 2 Pyrexia

Grade 3 Lung infection

Grade 2 Pneumonia

Grade 3 Blood alkaline phosphatase

Grade 2 Blood lactate dehydrogenase increased

Grade 3 Neutrophil count decreased

Grade 2 Decreased appetite

Grade 2 Muscular weakness

Grade 2 Squamous cell carcinoma

Grade 3 Syncope

Grade 2 Anxiety

Grade 2 Dyspnoea

Grade 2 Erythema multiforme

Grade 2 Rash

Grade 3 Rash

Grade 2 Skin exfoliation

Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)

Overall Study

Spots Global Cancer Trial Database for Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial