PLX3397

DRUG16 trials

Sponsors

Daiichi Sankyo, QuantumLeap Healthcare Collaborative, Plexxikon, Hope Rugo, MD, The Christie NHS Foundation Trust

Conditions

Acute Myeloid LeukemiaAngiosarcomaBreast CancerBreast NeoplasmsBreast TumorsEarly-stage Breast CancerGastrointestinal Stromal Tumor (GIST)HER2-negative Breast Cancer

Phase 1

Safety Study of PLX108-01 in Patients With Solid Tumors

CompletedNCT01004861

Daiichi SankyoSolid Tumor

Start: 2009-10-01End: 2018-10-25Updated: 2022-01-04

Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

WithdrawnNCT01090570

PlexxikonRheumatoid Arthritis

Start: 2010-05-31Updated: 2015-03-17

Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)

CompletedNCT01349049

Daiichi SankyoAcute Myeloid Leukemia

Start: 2011-11-21End: 2018-01-09Updated: 2020-03-02

Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

CompletedNCT01525602

Daiichi SankyoSolid Tumors

Start: 2012-05-31End: 2018-02-28Updated: 2020-07-16

Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

CompletedNCT01596751

Hope Rugo, MDMetastatic Breast Cancer

Start: 2012-07-12End: 2019-07-05Updated: 2020-07-17

A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma

CompletedNCT01790503

Daiichi SankyoPatients With Newly Diagnosed Glioblastoma

Start: 2013-07-18End: 2020-03-04Updated: 2020-06-30

A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

TerminatedNCT01826448

Daiichi SankyoStage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor, V600-mutated BRAF Metastatic Melanoma, V600-mutated BRAF Unresectable Melanoma

Start: 2013-11-05End: 2014-09-22Updated: 2020-05-28

A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors

TerminatedNCT02452424

Daiichi SankyoGastrointestinal Stromal Tumor (GIST), Melanoma, Non-small Cell Lung Cancer +2

Start: 2015-07-02End: 2018-10-12Updated: 2020-03-05

PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors

TerminatedNCT02584647

Gulam ManjiMalignant Peripheral Nerve Sheath Tumors, Sarcoma

Start: 2015-11-04End: 2024-10-01Updated: 2025-03-21

Phase 2

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

RecruitingNCT01042379

QuantumLeap Healthcare CollaborativeAngiosarcoma, Breast Cancer, Breast Neoplasms +8

Start: 2010-03-01End: 2031-12-01Target: 5000Updated: 2026-03-13

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

CompletedNCT01217229

Daiichi SankyoHodgkin Lymphoma

Start: 2011-03-03End: 2012-04-26Updated: 2020-06-30

A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

TerminatedNCT01349036

Daiichi SankyoRecurrent Glioblastoma

Start: 2011-12-03End: 2013-11-05Updated: 2020-03-03

Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)

TerminatedNCT01499043

Daiichi SankyoProstate Cancer

Start: 2012-05-25End: 2013-03-11Updated: 2020-03-04

PLX3397 KIT in Acral aNd mucOsal Melanoma

CompletedNCT02071940

The Christie NHS Foundation TrustMalignant Melanoma

Start: 2015-10-31End: 2021-03-02Updated: 2021-08-12

Phase 3

A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath - ENLIVEN

Active, not recruitingNL-OMON47179

Daiichi Sankyo, IncTumour of the tendon sheath

Start: 2015-11-25Target: 6Updated: 2024-02-28

Unknown Phase

A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

CompletedNCT02975700

Daiichi Sankyo Co., Ltd.Melanoma

Start: 2017-01-31End: 2024-10-11Updated: 2026-01-13

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