LymphomaPhase 1NCT03314922
A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
A Phase 1 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 6 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesJapan
- Study dates
- 2 Aug 2018to 9 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First generation Japanese; subject was born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry.
- Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
- Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
- Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Life expectancy > 3 months.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate hematologic, hepatic, and renal function.
Who cannot join
- Evidence of transformed non-Hodgkin's lymphoma histologies.
- Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
- Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.
- Active graft-versus-host disease.
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- History of stroke or intracranial hemorrhage within 6 months of study drug administration.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug.
- Known human immunodeficiency virus infection.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Aichi Cancer Center Hospital
Aichi, 464 8681
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
Nagoya City University Hospital
Nagoya, 467-8602
Tohoku University Hospital
Sendai, 980-8574
National Cancer Center Hospital
Tokyo, 104-0045
About this study
Official title: A Phase 1b, Open-Label, Dose-Escalation Study for the Safety, Tolerability, and Pharmacokinetics of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.
- Conditions
- Lymphoma
- Being tested
- Parsaclisib
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase (PI3K)
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib | Experimental | Not described Receives: Drug: Parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to approximately 1 year
Secondary outcomes (4)
Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
Markers of B-cell activation (eg, B-cell activating factor, interleukin-10, B-cell attracting chemokine) and other plasma analytes will be analyzed for correlation with safety and clinical outcome.
Measured: Up to 24 weeks
Objective response rate
Defined as the percentage of subjects with complete response (CR)/complete metabolic response (CMR) and partial response (PR)/ partial metabolic response (PMR), as determined by investigator assessment of response according to response criteria for lymphomas.
Measured: Up to approximately 1 year
Duration of response
Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among subjects who achieve an objective response.
Measured: Up to approximately 1 year
Progression-free survival
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression or death from any cause.
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start2 Aug 2018
- Primary completion5 May 2020
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cinthya Coronado, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314922
- Sponsor's protocol ID
- INCB 50465-111/CITADEL-111
- Other IDs
- Parsaclisib
- Status last verified
- Aug 2023
- First submitted
- 16 Oct 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available at the end of trial or termination of trial. The following data will be made available: safety, PK and PD, efficacy, and subject characteristics. The results of the trial will be published. In addition, data as documented in study CSR will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Escalation Study for the Safety, Tolerability, and Pharmacokinetics of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
- ClinicalTrials.gov ID
- NCT03314922
- Acronym / sponsor ID
- INCB 50465-111/CITADEL-111
- Conditions
- Lymphoma
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase (PI3K)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib | Experimental | Drug: Parsaclisib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First generation Japanese; subject was born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry.
- Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
- Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
- Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Life expectancy > 3 months.
Key exclusion criteria (10 listed)
- Evidence of transformed non-Hodgkin's lymphoma histologies.
- Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
- Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParsaclisibAlso: INCB050465Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose. | Drug | Parsaclisib |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 1 year
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
4 secondary outcomes
Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
Time frame: Up to 24 weeks
Objective response rate
Time frame: Up to approximately 1 year
Duration of response
Time frame: Up to approximately 1 year
Progression-free survival
Time frame: Up to approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Yes. Data will be made available at the end of trial or termination of trial. The following data will be made available: safety, PK and PD, efficacy, and subject characteristics. The results of the trial will be published. In addition, data as documented in study CSR will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cinthya Coronado, MD study director
Incyte Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.