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PI3Kδ inhibitor

INCB040093 + Itacitinib for B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have received ≥ 1 prior treatment regimen.

The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

Awards & highlights

Study Summary

This trial will test a new drug combination to find the best dose for people with relapsed or refractory B-cell malignancies.

Who is the study for?

Adults with B-cell lymphoma or other B-cell malignancies who have tried at least one treatment and aren't eligible for curative therapies like stem cell transplants. They should be in a condition to live at least 12 more weeks, not have brain involvement by cancer, and can't be recovering from recent cancer treatments or active infections.Check my eligibility

What is being tested?

The trial is testing INCB040093 alone and combined with itacitinib on people with B-cell cancers. It has three parts: finding the safest dose of INCB040093, then its combination with itacitinib, and finally evaluating these doses in patients whose disease returned after treatment.See study design

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to cancer drugs such as fatigue, nausea, liver issues, blood count changes, risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

Secondary outcome measures

Pharmacokinetic (PK) collections.

Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for Hodgkin's/non-Hodgkin's lymphoma (Cheson et al 2007 and Owen et al 2013) and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2012)

Trial Design

2Treatment groups

Experimental Treatment

Group I: INCB040093 in combination with itacitinib (INCB039110)Experimental Treatment1 Intervention

Group II: INCB040093Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,044 Total Patients Enrolled

Peter Langmuir, MDStudy DirectorIncyte Corporation

10 Previous Clinical Trials

908 Total Patients Enrolled

Media Library

INCB040093 (PI3Kδ inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01905813 — Phase 1

B-Cell Lymphoma Research Study Groups: INCB040093 in combination with itacitinib (INCB039110), INCB040093

B-Cell Lymphoma Clinical Trial 2023: INCB040093 Highlights & Side Effects. Trial Name: NCT01905813 — Phase 1

INCB040093 (PI3Kδ inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01905813 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the legal status of INCB040093 in the United States?

"INCB040093 is still being tested in Phase 1 clinical trials, so there is limited data to support its safety and efficacy. Consequently, our team at Power rates it a 1."

Answered by AI

Is INCB040093 a new or experimental drug?

"INCB040093 was initially evaluated in a study completed in 2013 (NCT01905813). Since then, there have been 12 more studies involving this medication. Currently, there are 23 active trials underway-- many of which are based out of Ann Arbor, Michigan."

Answered by AI

How many individuals are enrolled in this research project?

"This particular trial is no longer admitting patients. The study was first posted on 6/30/2013 and updated for the last time on 7/28/2022. However, there are 2461 other trials related to b-cell malignancies and 23 clinical studies specifically for INCB040093 that are still recruiting patients."

Answered by AI

Has this type of trial been attempted before?

"INCB040093 has a long clinical history, with the first study dating back to 2013. The original research was conducted by Incyte Corporation and involved 121 patients. After the successful Phase 1 trial, 23 more studies were opened in locations all over the world."

Answered by AI

Is this study being conducted in multiple locations within the city?

"Currently, this study is being conducted at 5 sites. The locations are in Ann Arbor, Rochester and New york as well as 2 other undisclosed places. If you decide to participate in this trial, please select the clinic that is closest to your location to limit travel time."

Answered by AI

Are there still opportunities for individuals to participate in this research?

"This particular clinical trial is not recruiting patients at the moment, according to the latest information on clinicaltrials.gov. The trial was originally posted on 6/30/2013 and was most recently updated on 7/28/2022. However, there are over 2,000 other medical studies currently looking for participants."

Answered by AI

Recent research and studies

BloodJournal

Phase 1 Study of the Pi3kδ Inhibitor INCB040093 ± JAK1 Inhibitor Itacitinib in Relapsed/refractory B-cell Lymphoma

Phillips, Tycel J., Andres Forero-Torres, Taimur Sher, Catherine S. Diefenbach, Patrick Johnston, Moshe Talpaz, Jennifer Pulini, et al.. 2018. “Phase 1 Study of the Pi3kδ Inhibitor INCB040093 ± JAK1 Inhibitor Itacitinib in Relapsed/refractory B-cell Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood-2017-10-812701.

clinicaltrials.govStudy

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

2013. "Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01905813.