B-Cell LymphomaPhase 1NCT02395601
A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
A Phase 1 study testing CPI-1205 in people with B-Cell Lymphoma, run by Constellation Pharmaceuticals at 6 sites in United States.
Trial summary
First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- CPI-1205
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged ≥ 18 years)
- Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
- Must give written informed consent to participate in this study before the performance of any study-related procedure
Who cannot join
- A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
- Treatment with proton pump inhibitors, H2 antagonists, or antacids
- Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
Show all 21Show fewer
- New York Heart Association Class III or IV congestive heart failure
- QTcF > 470 msec on the screening ECG
- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
- A past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
- Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
- Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI 1205
- Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-1205
- Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-1205.
- Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-1205.
- Treatment with medications that are strong inhibitors of CYP3A4
- Treatment with medications that are inducers of CYP3A4 enzymes
- Treatment with medications that are known to carry a risk of Torsades de Pointes
- Pregnant or lactating women
- Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
- Patients unwilling or unable to comply with this study protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Horizon Oncology Center
Lafayette, Indiana, 47905
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, in Patients With B-Cell Lymphomas
First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.
- Conditions
- B-Cell Lymphoma
- Being tested
- CPI-1205
- Keywords
- B-Cell Lymphoma, EZH2 Inhibitor, Phase 1
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-1205Drug
Small molecule inhibitor of the enzyme EZH2
| Study group | Role | What they receive |
|---|---|---|
| CPI-1205 | Experimental | Not described Receives: Drug: CPI-1205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Dose-limiting toxicities (DLTs)
Frequency of dose-limiting toxicities (DLTs) associated with CPI-1205 administration during the first cycle (first 28 days) of treatment
Measured: DLTs asessed during Cycle 1 (first 28 days on study)
Secondary outcomes (5)
Frequency of adverse events
Safety and tolerability of CPI-1205 as assessed by: frequency of adverse events and serious adverse events; changes in hematology and clinical chemistry values; changes in physical examination, vital signs, electrocardiogram, and ECOG score
Measured: Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug
Pharmacokinetic parameters of CPI-1205: AUC(0-t), AUC(0-inf), AUCtau,ss, Tmax, Cmax, Ctrough, T1/2, Vd/F, CL/F
Measured: Assessed during cycle 1 (first 28 days on study); and on cycle 2, day 1
Pharmacodynamic effects of CPI-1205 in lymphoma tissue: changes in levels of the trimethylated form of lysine residue 27 on histone 3; changes in the expression of genes whose transcription may be altered by EZH2 inhibition
Measured: Assessed during cycle 1 (first 28 days on study)
Pharmacodynamic effects of CPI-1205 in bone marrow and in skin: changes in global levels of the trimethylated form of lysine residue 27 on histone 3 (H3K27me3)
Measured: Assessed during cycle 1 (first 28 days on study)
Disease response assessment will be performed using the 2014 Lugano Response Criteria for Hodgkin and Non-Hodgkin Lymphoma
Measured: After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies of the same condition, open and under way.
- 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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Constellation Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395601
- Sponsor's protocol ID
- 1205-01
- Status last verified
- May 2022
- First submitted
- 10 Mar 2015
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, in Patients With B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT02395601
- Acronym / sponsor ID
- 1205-01
- Conditions
- B-Cell Lymphoma
- Keywords
- B-Cell Lymphoma, EZH2 Inhibitor, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Constellation PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Mar 2015 (estimated)
- 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.
First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPI-1205 | Experimental | Drug: CPI-1205 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (aged ≥ 18 years)
- Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
- Must give written informed consent to participate in this study before the performance of any study-related procedure
Key exclusion criteria (21 listed)
- A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
- Treatment with proton pump inhibitors, H2 antagonists, or antacids
- Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
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 |
|---|---|---|
| CPI-1205Small molecule inhibitor of the enzyme EZH2 | Drug | CPI-1205 |
Primary outcome
Frequency of Dose-limiting toxicities (DLTs)
Time frame: DLTs asessed during Cycle 1 (first 28 days on study)
Frequency of dose-limiting toxicities (DLTs) associated with CPI-1205 administration during the first cycle (first 28 days) of treatment
5 secondary outcomes
Frequency of adverse events
Time frame: Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug
Pharmacokinetic parameters of CPI-1205: AUC(0-t), AUC(0-inf), AUCtau,ss, Tmax, Cmax, Ctrough, T1/2, Vd/F, CL/F
Time frame: Assessed during cycle 1 (first 28 days on study); and on cycle 2, day 1
Pharmacodynamic effects of CPI-1205 in lymphoma tissue: changes in levels of the trimethylated form of lysine residue 27 on histone 3; changes in the expression of genes whose transcription may be altered by EZH2 inhibition
Time frame: Assessed during cycle 1 (first 28 days on study)
Pharmacodynamic effects of CPI-1205 in bone marrow and in skin: changes in global levels of the trimethylated form of lysine residue 27 on histone 3 (H3K27me3)
Time frame: Assessed during cycle 1 (first 28 days on study)
Disease response assessment will be performed using the 2014 Lugano Response Criteria for Hodgkin and Non-Hodgkin Lymphoma
Time frame: After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter
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 18 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CPI-1205 in people with B-Cell Lymphoma, run by Constellation Pharmaceuticals at 6 sites in United States.
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 5 inclusion and 21 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 18 May 2022. 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 United States. 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?
Frequency of Dose-limiting toxicities (DLTs) (time frame: DLTs asessed during Cycle 1 (first 28 days on study)). 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 18 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.