Daiichi Sankyo Begins Patient Dosing In Phase 2 Trial Of Pexidartinib To Treat Tenosynovial Giant Cell Tumor

Daiichi Sankyo Company Announced That The First Patient Was Dosed In A Phase 2 Study To Evaluate The Safety And Efficacy Of Pexidartinib, A Csf-1R Inhibitor, In Japanese Patients With Symptomatic Tenosynovial Giant Cell Tumor (Tgct) Associated With Severe Morbidity Or Functional Limitation And Not Amenable To Improvement With Surgery.Tgct, Also Referred To As Pigmented Villonodular Synovitis (Pvns) Or Giant Cell Tumor Of The Tendon Sheath (Gct-Ts) Is A Rare, Typically Non-Malignant Tumor That Can Be Locally Aggressive. Tgct Affects The Synovium-Lined Joints, Bursae And Tendon Sheaths, Resulting In Reduced Mobility In The Affected Joint Or Limb. For Most Patients, The Current Standard Of Care For Tgct Is Surgery; However, In More Severe Cases, The Tumor May Be Difficult To Remove And/Or May Not Improve With Surgery. Multiple Surgeries Can Lead To Significant Joint Damage, Debilitating Functional Impairments, And Reduced Quality Of Life, And Amputation May Be Considered.&Ldquo;We Are Committed To Continuing To Explore The Clinical Benefit Of Pexidartinib In Patients With Tgct, A Disease Which Can Be Associated With Severe Morbidity, Functional Limitations And May Not Be Amenable To Improvement With Surgery,&Rdquo; Said Wataru Takasaki, Phd, Executive Officer, Head Of R&Amp;D Division In Japan, Daiichi Sankyo. &Ldquo;This Study Will Further Serve To Inform Our Development Path Forward In Japan And Provide Additional Research Insights To Better Understand This Debilitating Disease And The Role Pexidartinib May Potentially Play In Japanese Patients With Tgct Who Are In Need Of Alternative Treatment Options.&Rdquo;This Phase 2, Multicenter, Two-Part, Open-Label, Single-Arm Study Will Evaluate The Safety And Efficacy Of Pexidartinib In Japanese Patients With Symptomatic Tgct Associated With Severe Morbidity Or Functional Limitation And Not Amenable To Improvement With Surgery.Approximately 18 Patients Will Be Enrolled Into The Two-Part Study. In The First Part, Pexidartinib 800 Mg/Day (400 Mg Twice A Day On An Empty Stomach) Will Be Administered To Evaluate The Tolerability And Pharmacokinetics Of Pexidartinib To Determine The Initiation Of The Second Part Of The Study. In The 2 Second Part, Pexidartinib 800 Mg/Day (400 Mg Twice A Day On An Empty Stomach) Will Be Administered And Efficacy, Safety, And Pharmacokinetics Of Pexidartinib Will Be Evaluated.The Primary Trial Endpoints Are Dose-Limiting Toxicity, An Analysis Of Pharmacokinetics And Objective Response Rate (Orr), Assessed By Recist Version 1.1. Key Secondary Endpoints Include Orr By Tumor Volume Score, Range Of Motion, Patient Reported Outcomes, And Treatment-Emergent Adverse Events.Tgct, Also Referred To As Pigmented Villonodular Synovitis (Pvns) Or Giant Cell Tumor Of The Tendon Sheath (Gct-Ts), Is A Rare, Typically Non-Malignant Tumor That Can Be Locally Aggressive.The Current Standard Of Care For Tgct Is Surgical Resection. However, In Patients With Diffuse-Type Tgct, The Tumor May Wrap Around Bone, Tendons, Ligaments And Other Parts Of The Joint. In These Cases, The Tumor May Be Difficult To Remove And/Or May Not Be Amenable To Improvement With Surgery. Multiple Surgeries For More Severe Cases Can Lead To Significant Joint Damage, Debilitating Functional Impairments And Reduced Quality Of Life, And Amputation May Be Considered.Pexidartinib Is An Oral Small Molecule That Inhibits Csf-1R (Colony Stimulating Factor-1 Receptor), Which Is A Primary Growth Driver Of Abnormal Cells In The Synovium That Cause Tgct. Pexidartinib Also Inhibits Kit And Flt3-Itd. Pexidartinib Was Discovered By Plexxikon Inc., The Small Molecule Structure-Guided R&Amp;D Center Of Daiichi Sankyo.

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