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duvelisib

Phase 2

Lymphoma | Small molecule | Oncology |AbbVie Inc.|Trials Updated: Feb 6, 2017

duvelisib development status

Highest phase Phase 2 run by Emory University (NCT04487886)
Phase scored for ABBVPhase 1
Registered trials 6 across 4 sponsors since Nov 2015

duvelisib target and mechanism

Molecular targetPIK3CG, PIK3CD
Target classInhibitor
ModalitySmall molecule

Also known as IPI-145, ABBV-954

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

duvelisib clinical trials

duvelisib · 1 trial · 1 indication

Phase 1 1
NCT02598570Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory LymphomaLymphoma
COMPLETED7 Analytics
PHASE1COMPLETED
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants reporting Treatment-emergent Adverse Events
Throughout the study for approximately 2 years

The number of participants reporting treatment-emergent adverse events.

Maximum Observed Plasma Concentration (Cmax) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Time to Maximum Observed Concentration (Tmax) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5

Secondary Endpoints

Overall Response Rate
Throughout the study for approximately 2 years
Overall Survival
Throughout the study for approximately 2 years
Progression Free Survival
Throughout the study for approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
duvelisibEXPERIMENTALDuvelisib will be administered orally as a fixed dose in 28-day cycles.

Interventions

NameTypeDescription
duvelisibDRUGDuvelisib will be administered orally as a fixed dose in 28-day cycles.
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Eligibility Criteria

Age Range20 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosis of lymphoma (excluding lymphoblastic lymphoma) * Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy * Eastern Cooperative Oncology Group (ECOG) performance status lower th...

Countries:Japan
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Competitive Landscape -Lymphoma 494 trials

Top 20 of 70 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, REGN5837
Merck & Co., Inc.MRK22PHASE3Nemtabrutinib, Zilovertamab vedotin, Pembrolizumab Berahyaluronidase alfa, Pembrolizumab, MK-1045
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, LY4152199, LY4584180
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Surovatamig, AZD0486, AZD4512, AZD5492
Novartis AG Sponsored ADRNVS9PHASE3Tisagenlecleucel, Rapcabtagene autoleucel, PIT565, Tulmimetostat
Incyte CorporationINCY16PHASE3Tafasitamab, parsaclisib, Ruxolitinib
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, KITE-753, KTE-X19, KITE-197, INT2104
AbbVie, Inc.ABBV14PHASE3Venetoclax, Epcoritamab, ABBV-319, ABBV-453, ABBV-525
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab
Johnson & JohnsonJNJ15PHASE3Ibrutinib, Bortezomib, JNJ-90009530, JNJ-80948543, JNJ-75348780
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Tacabrutideg, Zanubrutinib, Lenalidomide, Tislelizumab, Sonrotoclax
Bristol-Myers Squibb CompanyBMY19PHASE3Golcadomide, Lenalidomide, Lisocabtagene maraleucel, Nivolumab, CC-122
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Axitinib, Bosutinib, Crizotinib
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, NX-1607, NX-2127
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
ADC Therapeutics LtdADCT3PHASE3Loncastuximab tesirine
Cellectar Biosciences, Inc.CLRB3PHASE3Iopofosine I-131
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib
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Frequently asked questions about duvelisib

What is duvelisib used for?

Duvelisib is being studied for the treatment of lymphoma. The clinical program described here focuses on Japanese subjects with relapsed or refractory lymphoma, a cancer of the lymphatic system. Duvelisib is an investigational small molecule and is not described as approved for this use.

What does duvelisib target?

Duvelisib targets PIK3CG and PIK3CD, two isoforms of phosphoinositide 3-kinase. It acts as an inhibitor of these targets. By inhibiting PIK3CG and PIK3CD, duvelisib interferes with signaling pathways involved in the growth and survival of lymphoma cells.

Who is developing duvelisib?

Duvelisib is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical program for duvelisib in lymphoma.

What phase is duvelisib in?

Duvelisib is in Phase 1 clinical development for lymphoma. The program includes one completed Phase 1 trial. Duvelisib is investigational and is not described as approved.

What clinical trials is duvelisib in?

Duvelisib has been evaluated in a Phase 1 trial, NCT02598570, titled "Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma." The trial enrolled 7 subjects in Japan and is completed. It was an uncontrolled study without randomization or blinding.