- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949883
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
March 7, 2024 updated by: Constellation Pharmaceuticals
A Phase 1 Study of CPI-0610, a Small Molecule Inhibitor of BET (Bromodomain and Extra-terminal) Proteins, in Patients With Progressive Lymphoma
First in human, open-label, sequential dose escalation and expansion study of CPI-0610 in patients with progressive lymphoma.
CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults (aged ≥ 18 years)
- Histologically confirmed diagnosis of a non-Hodgkin or Hodgkin lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
- Patients may have either measurable or non-measurable disease, but in all cases eligible patients must have disease that can be clinically evaluated for improvement or progression
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
- Written informed consent to participate in this study before the performance of any study-related procedure
Exclusion Criteria:
- A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS. CNS imaging and cerebrospinal fluid sampling are not mandatory in the absence of a clinical suspicion of lymphomatous involvement of the CNS.
- Current infection with HIV, Hepatitis B or Hepatitis C. Patients will have serologic testing performed during screening for HIV and Hepatitis B and C. Any serologic results suggestive of an ongoing viral infection will be further investigated as necessary to clarify the patient's status.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-0610, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1.
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
- Serum cardiac troponin (cTn) level ≥ 99% percentile of the upper reference limit
- QTcF > 470 msec on the screening ECG
- Left ventricular ejection fraction (LVEF) < 40%
- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
- 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-0610
- Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-0610
- Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed.
- Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-0610. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of CPI-0610 may be permitted in patients with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor.
- Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes.
- Treatment with medications that are known to carry a risk of Torsades de Pointes.
- Immunosuppressive treatment that cannot be discontinued both prior to study entry and for the duration of the study. Oral prednisone at a dose of 10 mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPI-0610
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of dose-limiting toxicities (DLTs) associated with CPI-0610 administration during the first cycle (first 21 days) of treatment
Time Frame: DLTs asessed during Cycle 1 (first 21 days on study)
|
DLTs asessed during Cycle 1 (first 21 days on study)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of CPI-0610 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, ECHO and ECOG score
Time Frame: Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug
|
Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug
|
Pharmacokinetic parameters of CPI-0610: AUC(0-t), AUC(0-inf), AUCtau,ss, Tmax, Cmax, Ctrough, T1/2, Vd/F, CL/F
Time Frame: Assessed during cycle 1 (first 21 days on study); and on cycle 2, day 1
|
Assessed during cycle 1 (first 21 days on study); and on cycle 2, day 1
|
Changes in the expression of a set of genes in peripheral blood mononuclear cells (PBMCs) that are sensitive to BET inhibition
Time Frame: Assessed during cycle 1 (first 21 days on study)
|
Assessed during cycle 1 (first 21 days on study)
|
Pharmacodynamic effects of CPI-0610: Changes in the expression of MYC and other genes in tumor tissue; changes in cellular proliferation and in the extent of apoptosis; changes in tumor metabolism
Time Frame: Assessed during cycle 1 (first 21 days on study); and on cycle 2, day 1
|
Assessed during cycle 1 (first 21 days on study); and on cycle 2, day 1
|
Anti-lymphoma activity associated with CPI-0610 treatment
Time Frame: After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter; assessed up to approximately 12 months
|
After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter; assessed up to approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2013
Primary Completion (Actual)
December 20, 2017
Study Completion (Actual)
February 7, 2018
Study Registration Dates
First Submitted
September 10, 2013
First Submitted That Met QC Criteria
September 24, 2013
First Posted (Estimated)
September 25, 2013
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0610-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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