A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma
Conditions: Keywords
Phase 1, Oncology, BET Inhibitor
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CPI-0610
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Colorado Blood Cancer Institute
Denver, Colorado, United States
Status: Recruiting
Contact: Juli Murphy - 720-754-4890
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Jeremy Abramson, MD - 617-724-4000
John Theurer Cancer Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Leah Cappadona - 551-996-5078
Memorial Sloan Ketttering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Amy Copeland, RN, MSN, CNS - 212-639-6104
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
Status: Recruiting
Contact: Kristie Blum, MD - 614-293-7807
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Status: Recruiting
Contact: Sarah Cannon Research Institute - 877-691-7274
Start Date
September 2013
Completion Date
May 2016
Sponsors
Constellation Pharmaceuticals
Source
Constellation Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page