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PCI-24781

Phase 1

Lymphoma | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 7, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

PCI-24781 · 3 trials · 9 indications

Phase 1 3
NCT01149668A Safety and Tolerability Study of PCI-24781 in Subjects With CancerLymphoma
COMPLETED7 Analytics
NCT00724984Study of the Safety and Tolerability of PCI-24781 in Patients With LymphomaLymphoma
COMPLETED55 Analytics
NCT00562224Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer PatientsNeoplasms by Site
COMPLETED36 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of PCI-24781 in Subjects With Cancer
LymphomaUnlock trial analytics
PHASE1COMPLETED
Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma
LymphomaUnlock trial analytics
PHASE1COMPLETED
Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients
Neoplasms by SiteUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
30 days after last dose of study drug

frequency, severity and relatedness of adverse events

Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response
From the Date of PCI-24781 first administration to Cycle 2 Day 1

Number of patients experienced DLT in each cohort

Phase II: Overall Response Rate (CR+PR)
From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles
Dose limiting toxicity assessment at the end of the first 28 day cycle.
at the end of the first 28 day cycle

Secondary Endpoints

Tumor Response
frequency of tumor assessments done per standard of care
Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Tumor response Measure: Pharmacokinetic/Pharmacodynamic assessments
AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PCI-24781EXPERIMENTAL -
1EXPERIMENTAL -
Arm 1EXPERIMENTALAll study subjects will receive PCI-24781 (study drug).

Interventions

NameTypeDescription
PCI-24781DRUGSubjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Men and women with cancer that did not progress while treated with PCI 24781 PO for at least 6 months and who want to continue receiving study drug 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Agreement to use contraception during the study and fo...

Countries:United States
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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 PCI-24781

What is PCI-24781 used for?

PCI-24781 is an investigational small molecule being studied for the treatment of lymphoma and other neoplasms by site. It has been evaluated in patients with non-Hodgkin lymphoma, Hodgkin disease, multiple myeloma, and chronic lymphocytic leukemia. The drug is in Phase 1 clinical development and is not yet approved.

Who makes PCI-24781?

PCI-24781 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 of this investigational oncology drug in the United States.

What phase is PCI-24781 in?

PCI-24781 is in Phase 1 clinical development. Three Phase 1 trials have been completed, with a total enrollment of 62 patients. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials has PCI-24781 been in?

PCI-24781 has been studied in three completed Phase 1 trials: NCT00562224, NCT00724984, and NCT01149668. These trials assessed the safety and tolerability of the drug in patients with advanced cancer, lymphoma, and other hematologic malignancies. All trials were conducted in the United States.

How is PCI-24781 administered?

PCI-24781 is administered as an oral capsule. The clinical trials evaluated the safety and tolerability of this oral formulation in adult patients with cancer, including those with lymphoma and related conditions.

Is PCI-24781 the same as abexinostat?

PCI-24781 is also known as abexinostat. It is a small molecule oncology drug being developed by AbbVie Inc. for the treatment of lymphoma and other cancers. The drug is currently in Phase 1 clinical development.