Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma (PCYC-0403)
This study is ongoing, but not recruiting participants.
Sponsor:
Pharmacyclics
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00724984
First received: July 28, 2008
Last updated: June 1, 2012
Last verified: June 2012
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Purpose
The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin |
Drug: PCI-24781 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- Measure: Dose limiting toxicity assessment for each patient at the end of the first 28 day cycle (Phase 1) Measure: Disease response [ Time Frame: At the end of every 2 cycle ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Pharmacokinetic/Pharmacodynamic assessments [ Time Frame: After every 2 cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 62 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: PCI-24781
Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart ("BID"), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I. Other Name: PCI-24781
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• age ≥ 18 years
- Phase I: Any measurable, histologically confirmed, and previously treated lymphoma
Phase II: Measurable, histologically confirmed, and previously treated lymphoma in one of the following categories:
- Follicular non-Hodgkin's Lymphoma
- Mantle cell lymphoma
- Ability to swallow oral capsules without difficulty
- Estimated life expectancy > 12 weeks
- ECOG performance status ≤ 1
- Willing and able to sign a written informed consent
Exclusion Criteria:
• More than four prior systemic treatment regimens (not counting maintenance rituximab; salvage therapy/conditioning regimen preceding autologous bone marrow transplantation [ABMT] and ABMT count as one regimen)
- Allogeneic bone marrow transplant
- Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks before first day of study drug dosing
- Major surgery within 4 weeks before first day of study drug dosing
- CNS lymphoma or a history of meningeal carcinomatosis
- Prior treatment with an HDAC inhibitor (unless for treatment of Mycosis fungoides or Sézary syndrome)
- Creatinine > 1.5 x institutional upper limit of normal (ULN) or creatinine clearance ≤ 50 mL/min
- Total bilirubin > 1.5 x institutional ULN (unless elevated from documented Gilbert's syndrome)
- AST and ALT > 2.5 x institutional ULN
- Platelet count < 75,000/µL for Phase I and <100,000>µL for Phase II
- Absolute neutrophil count (ANC) < 1500/µL
- Malabsorption
- Corticosteroids > 20 mg prednisone equivalent per day (topical, inhaled, or nasal corticosteroids are permitted)
- Concurrent therapeutic anticoagulation (Phase I only)
- Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
- Risk factors for, or use of drugs known to prolong QTc interval or that may be associated
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724984
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Northwestern University Medicial School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Horizon Oncology Center | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Massachusetts | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| Nebraska Methodist Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Vermont | |
| University of Vermont and Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05405 | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Study Director: | Lei Zhou, MD | Pharmacyclics |
More Information
Additional Information:
Publications:
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00724984 History of Changes |
| Other Study ID Numbers: | PCYC-0403 |
| Study First Received: | July 28, 2008 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
PCI-24781 Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular |
Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013