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Small Molecule Inhibitor
CPI-0209 for Cancer and Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Constellation Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort M5: Pleural or peritoneal relapsed/refractory mesothelioma, progressed on or after at least 1 prior line of active therapy, measurable disease per modified RECIST 1.1 for pleural mesothelioma or by RECIST 1.1 for peritoneal mesothelioma, known BAP1 loss per immunohistochemistry (IHC) or NGS
Cohort M2: Histologically confirmed advanced ovarian clear cell carcinoma, known ARID1A mutation, received at least 1 line of platinum-based chemotherapy, measurable disease per RECIST 1.1, disease progression after previously receiving effective and available standard of care treatment for clear cell ovarian cancer per local clinical practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is testing a new drug, CPI-0209, to see if it's safe and effective in treating patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.
Who is the study for?
This trial is for adults with various advanced cancers, including ovarian, endometrial, mesothelioma, prostate cancer and lymphomas. Participants must have a life expectancy of at least 12 weeks and be in good physical condition (ECOG 0-1). They should have tried standard treatments without success and meet specific criteria like certain genetic mutations or hormone levels depending on the cancer type.Check my eligibility
What is being tested?
CPI-0209 is being tested; it's a new drug that targets EZH2, an enzyme involved in cancer growth. The study has two phases: dose escalation to find the safe dosage level and expansion to test its effectiveness across different types of advanced solid tumors and lymphomas.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions seen with other similar drugs such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function abnormalities, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mesothelioma has returned or didn't respond to treatment, and it shows BAP1 loss.
Select...
I have advanced ovarian clear cell cancer with an ARID1A mutation, have had platinum-based chemotherapy, and my cancer has progressed after standard treatments.
Select...
My cancer has spread, is growing despite treatment, and I'm undergoing hormone therapy to lower testosterone.
Select...
My advanced cancer has not responded to standard treatments.
Select...
I am expected to live more than 12 weeks, can move around well, and my kidneys, liver, and bone marrow are functioning properly.
Select...
My cancer is advanced bladder cancer with a specific mutation and has worsened despite treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Phase 2: Overall response rate (ORR)
Secondary outcome measures
Phase 1 Adverse events (AEs) and change in laboratory values
Phase 1: Disease control rate
Phase 1: Duration of response (DOR)
+17 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort M6Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M6 patients with castration-resistant prostate cancer(mCRPC) with measurable soft tissue disease
Group II: Phase 2 Cohort M5Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M5 patients with relapsed or refractory malignant pleural or peritoneal mesothelioma with known BAP1 loss
Group III: Phase 2 Cohort M4Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M4 patients with peripheral T-cell lymphoma (PTCL) and patients with diffuse large B-cell lymphoma (DLBCL), including patients with documented germinal center B cell like diffuse large B-cell lymphoma (GCB-DLBCL) with at least 1 EZH2 hotspot mutation
Group IV: Phase 2 Cohort M3Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M3 patients with endometrial carcinoma (with known ARID1A mutation)
Group V: Phase 2 Cohort M2Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M2 patients with ovarian clear cell carcinoma (with known ARID1A mutation)
Group VI: Phase 2 Cohort M1Experimental Treatment1 Intervention
CPI-0209 will be dosed once per day orally in 28 day cycles.
• Cohort M1: patients with urothelial carcinoma or other advanced/metastatic solid tumors (with known ARID1A mutation)
Find a Location
Who is running the clinical trial?
Constellation PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
1,257 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active symptoms of hepatitis or chronic liver disease.I have PTCL or DLBCL, my treatment hasn't worked, and I can't have a transplant.I have or might have lung inflammation or scarring.I don't have stomach issues affecting my medication absorption.I have a serious heart condition.I haven't had major surgery in the last 4 weeks or still recovering from one.My mesothelioma has returned or didn't respond to treatment, and it shows BAP1 loss.I do not have another type of cancer at the same time.I haven't taken strong CYP3A affecting drugs or consumed related foods or beverages in the last 7 days.I have advanced ovarian clear cell cancer with an ARID1A mutation, have had platinum-based chemotherapy, and my cancer has progressed after standard treatments.I haven't needed IV drugs for an infection in the last 2 weeks.I have endometrial cancer with specific genetic features, have tried standard treatments, and my disease is measurable.I have had a transplant of an organ or bone marrow.My cancer has spread, is growing despite treatment, and I'm undergoing hormone therapy to lower testosterone.My advanced cancer has not responded to standard treatments.I am expected to live more than 12 weeks, can move around well, and my kidneys, liver, and bone marrow are functioning properly.I do not have any severe uncontrolled health conditions or serious psychiatric illnesses.I have not had cancer treatment within the specified time.I have had radiation therapy recently.I have had chemoembolization or radioembolization recently.I have been treated with an EZH2 inhibitor before.I have brain metastases that haven't been treated and are causing symptoms.My cancer is advanced bladder cancer with a specific mutation and has worsened despite treatment.I have not used any herbal products that could affect my PSA levels, and I am following a specific treatment plan for prostate cancer.I do not have an active or chronic infection with HIV, hepatitis B, or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Cohort M4
- Group 2: Phase 2 Cohort M6
- Group 3: Phase 2 Cohort M1
- Group 4: Phase 2 Cohort M5
- Group 5: Phase 2 Cohort M3
- Group 6: Phase 2 Cohort M2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the conditions that CPI-0209 has been shown to be most effective against?
"CPI-0209 is most commonly used to treat malignant neoplasms of the pancreas. It can also be effective in treating other conditions like neoplasm metastasis, malignant neoplasm of stomach, and rhabdomyosarcoma."
Answered by AI
Does CPI-0209 have a history of successful clinical trials?
"514 clinical trials have been completed for CPI-0209 since it was first studied in 2002 at Mayo Clinic. At the present moment, there are 275 active studies being conducted all over the world, with a notable concentration in Cincinnati, Ohio."
Answered by AI
Are there any available positions for volunteers in this experiment?
"This research is ongoing, as indicated by the listing on clinicaltrials.gov. The original posting was on September 18th, 2019 with a most recent edit taking place on October 4th, 2022."
Answered by AI
How many different medical clinics are participating in this study?
"Presently, there are 14 sites enrolling patients for this clinical trial. To name a few locations, these sites are in Cincinnati, New york and Chicago. If you participate in this trial, it is important to select the site nearest you to cut down on travel time."
Answered by AI
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