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duvelisib

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

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 338 trials

Top 20 of 66 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
AstraZeneca PLCAZN14PHASE3Surovatamig, R-CHOP, R-CVP, BR
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles, Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC20PHASE3BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide
Bristol-Myers Squibb CompanyBMY17PHASE3Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Johnson & JohnsonJNJ11PHASE3Ibrutinib
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
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Frequently asked questions about duvelisib

What is duvelisib used for in lymphoma?

Duvelisib is an investigational small molecule being studied for the treatment of lymphoma. It is being evaluated in patients with relapsed or refractory lymphoma, meaning the cancer has returned or has not responded to prior treatment. The drug is currently in Phase 1 clinical development for this indication.

Who makes duvelisib?

Duvelisib is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with lymphoma.

What phase is duvelisib in?

Duvelisib is in Phase 1 clinical development for the treatment of lymphoma. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients.

What clinical trials is duvelisib in?

Duvelisib has been studied in a Phase 1 clinical trial with the identifier NCT02598570. This trial evaluated the drug in Japanese subjects with relapsed or refractory lymphoma. The study has been completed and enrolled a total of 7 participants.

Is duvelisib FDA approved?

Duvelisib is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of lymphoma. The drug has not completed the clinical trial process necessary to obtain regulatory approval, and its safety and efficacy have not been fully established.