NCT00724984

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P75+ for phase_1 lymphoma

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

February 1, 2014

Enrollment Period

4.3 years

First QC Date

July 28, 2008

Results QC Date

February 27, 2014

Last Update Submit

February 27, 2014

Conditions

LymphomaHodgkin DiseaseLymphoma, Non-Hodgkin

Keywords

PCI-24781LymphomaHodgkin DiseaseLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle CellLymphoma, T-Cell, CutaneousLymphoma, T-Cell, Peripheral

Outcome Measures

Primary Outcomes (2)

  • Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response

    Number of patients experienced DLT in each cohort

    From the Date of PCI-24781 first administration to Cycle 2 Day 1

  • Phase II: Overall Response Rate (CR+PR)

    From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles

Study Arms (1)

1

EXPERIMENTAL
Drug: PCI-24781

Interventions

PCI-24781DRUG

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Northwestern University Medical School

Chicago, Illinois, 60611, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Vermont and Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • 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. doi: 10.1158/1535-7163.MCT-05-0442.

    PMID: 16731764RESULT

Related Links

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-CellLymphoma, T-Cell, CutaneousLymphoma, T-Cell, Peripheral

Interventions

abexinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-Cell

Results Point of Contact

Title
Dr. Thorsten Graef
Organization
Pharmacyclics
pharmacyclics@medcomsol.com
855-427-8846

Study Officials

  • Thorsten Graef, MD

    Pharmacyclics LLC.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2012

Last Updated

April 7, 2014

Results First Posted

April 7, 2014

Record last verified: 2014-02

Locations

US(8)