NCT00562224

Brief Summary

To determine the highest dose of study drug that can be taken without causing serious side effects in patients with advanced cancer. The study will look at safety of the study drug and whether the treatment schedule is tolerated by patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

Typical duration for phase_1

Geographic Reach
1 country

4 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

November 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

2.6 years

First QC Date

November 19, 2007

Last Update Submit

September 26, 2011

Conditions

Neoplasms by SiteLymphoma, Non-hodgkinHodgkin DiseaseMultiple MyelomaLeukemia, Lymphocytic, Chronic

Keywords

PCI-24781Neoplasms by siteLymphoma, non-hodgkinHodgkin diseaseMultiple myelomaLeukemia, lymphocytic, chronic

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity assessment at the end of the first 28 day cycle.

    at the end of the first 28 day cycle

Secondary Outcomes (1)

  • Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Tumor response Measure: Pharmacokinetic/Pharmacodynamic assessments

    AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1

Study Arms (1)

Arm 1

EXPERIMENTAL

All study subjects will receive PCI-24781 (study drug).

Drug: PCI-24781

Interventions

PCI-24781DRUG

Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart ("TID"), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart ("BID"). If a DLT occurs on the "BID" schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached.

Arm 1

Eligibility Criteria

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

You may qualify if:

  • age ≥ 18 years
  • Histologically confirmed, measurable solid tumor, non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, or multiple myeloma that has relapsed after standard therapy or for which no standard therapy exists
  • Ability to swallow oral capsules without difficulty
  • Estimated life expectancy \> 12 weeks
  • ECOG performance status ≤ 2
  • Creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 × institutional ULN (unless elevated from documented Gilbert's syndrome)
  • AST and ALT ≤ 2.5 × institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases)
  • Platelet count ≥ 100,000/µL
  • ANC ≥ 1500/µL
  • Hgb ≥ 9.0 g/dL
  • Patients with previously treated, stable, asymptomatic brain metastases who are not on corticosteroids are eligible
  • Willing and able to sign a written informed consent-

You may not qualify if:

  • Patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to first day of drug dosing
  • Patients who have undergone major surgery within 4 weeks prior to first day of drug dosing
  • Patients who have received another investigational drug within 4 weeks
  • Evidence of leptomeningeal metastasis
  • Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (eg, WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy)
  • 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
  • Patients with risk factors for, or who are receiving medications known to prolong QTc interval and that may be associated with Torsades de Pointes
  • QTc prolongation (defined as a QTc interval ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
  • Patients with known HIV infection
  • Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

California Cancer Care

Greenbrae, California, 94904, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Sarah Cannon Research Institue

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, 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: 16731764BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms by SiteLymphoma, Non-HodgkinHodgkin DiseaseMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

abexinostat

Condition Hierarchy (Ancestors)

NeoplasmsLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samir Undevia, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

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

November 19, 2007

First Posted

November 21, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

US(4)