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Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma (PCYC-0403)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00724984
First received: July 28, 2008
Last updated: June 1, 2012
Last verified: June 2012
History of Changes

July 28, 2008
June 1, 2012
July 2008
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00724984 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
 
 
Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma
Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma

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.
 
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
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
Experimental: 1
Intervention: Drug: PCI-24781
Buggy JJ, Cao ZA, Bass KE, Verner E, Balasubramanian S, Liu L, Schultz BE, Young PR, Dalrymple SA. CRA-024781: a novel synthetic inhibitor of histone deacetylase enzymes with antitumor activity in vitro and in vivo. Mol Cancer Ther. 2006 May;5(5):1309-17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
February 2013
December 2012   (final data collection date for primary outcome measure)

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:

      1. Follicular non-Hodgkin's Lymphoma
      2. 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00724984
PCYC-0403
No
Pharmacyclics
Pharmacyclics
 
Study Director: Lei Zhou, MD Pharmacyclics
Pharmacyclics
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP