Therapy Detail

Therapy Name Parsaclisib
Synonyms
Therapy Description

Parsaclisib (INCB050465) inhibits PI3K-delta, blocking activation of AKT signaling pathway and leading to apoptosis of PIK3CD expressing tumor cells (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Parsaclisib INCB050465 PIK3CD inhibitor 24 Parsaclisib (INCB050465) inhibits PI3K-delta, blocking activation of AKT signaling pathway and leading to apoptosis of PIK3CD expressing tumor cells (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown marginal zone B-cell lymphoma not applicable Parsaclisib Phase Ib/II Actionable In a Phase I/II trial, Parsaclisib (INCB050465) treatment demonstrated tolerability and preliminary activity in patients with refractory B-cell malignancies, and resulted in an overall response rate of 78% (7/9), complete response/complete metabolic response rate of 33% (3/9), and median duration of response of 4.4 months in patients with marginal zone lymphoma (PMID: 30803990; NCT02018861). 30803990
Unknown unknown diffuse large B-cell lymphoma not applicable Parsaclisib Preclinical - Cell line xenograft Actionable In a preclinical study, Parsaclisib (INCB050465) inhibited proliferation of diffuse large B-cell lymphoma cell lines in culture and suppressed tumor growth in xenograft models (Cancer Res August 1, 2015 75; 2671). detail...
Unknown unknown diffuse large B-cell lymphoma not applicable Parsaclisib Phase Ib/II Actionable In a Phase I/II trial, Parsaclisib (INCB050465) treatment demonstrated tolerability and preliminary activity in patients with refractory B-cell malignancies, and resulted in an overall response rate of 30% (7/23), complete response/complete metabolic response rate of 17% (4/23), and median duration of response of 13.5 months in patients with diffuse large B-cell lymphoma (PMID: 30803990; NCT02018861). 30803990
Unknown unknown mantle cell lymphoma not applicable Parsaclisib Phase Ib/II Actionable In a Phase I/II trial, Parsaclisib (INCB050465) treatment demonstrated tolerability and preliminary activity in patients with refractory B-cell malignancies, and resulted in an overall response rate of 67 (6/9), complete response/complete metabolic response rate of 44% (4/9), and median duration of response was not reached in patients with mantle cell lymphoma (PMID: 30803990; NCT02018861). 30803990
Unknown unknown follicular lymphoma not applicable Parsaclisib Phase Ib/II Actionable In a Phase I/II trial, Parsaclisib (INCB050465) treatment demonstrated tolerability and preliminary activity in patients with refractory B-cell malignancies, and resulted in an overall response rate of 71% (10/14), complete response/complete metabolic response rate of 21% (3/14), and median duration of response was not reached patients with follicular lymphoma (PMID: 30803990; NCT02018861). 30803990
Unknown unknown Advanced Solid Tumor not applicable Parsaclisib Preclinical Actionable In a preclinical study, Parsaclisib (INCB050465) demonstrated immunomodulatory and anti-tumor activity in mouse tumor models with intact immune systems (Mol Cancer Ther December 1 2015 (14) (12 Supplement 2) C103). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03126019 Phase II Parsaclisib Idelalisib An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) Recruiting
NCT02018861 Phase I Itacitinib Itacitinib + Parsaclisib Bendamustine Rituximab Carboplatin + Etoposide + Ifosfamide Parsaclisib A Phase 1, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 Monotherapy and in Combination With INCB039110 in Subjects With Previously Treated B-Cell Malignancies Active, not recruiting
NCT03235544 Phase II Parsaclisib A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205) Recruiting
NCT02998476 Phase II Parsaclisib A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202) Active, not recruiting
NCT03144674 Phase II Parsaclisib A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) Recruiting


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