Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

NCT00473577 | Completed Phase 1 DMC

• 1 other identifier: PCYC 0401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous infusions in patients with refractory solid or hematologic malignancies. To evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of CRA-024781 IV when administered in a single oral dose.

Conditions

Hematologic Neoplasms; Neoplasms

Interventions

CRA-24781 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• histologically confirmed solid or hematologic malignancy that is refractory to standard therapy or for which no standard therapy exists
• estimated life expectancy \> 12 weeks
• ECOG performance grade ≤ 2
• creatinine ≤ 1.5 X institutional upper limit of normal or creatinine clearance \> 50 mL/min
• total bilirubin within institutional limits (unless elevated from documented Gilbert's syndrome)
• AST and ALT ≤ 2.5 X institutional upper limit of normal (≤ 5 x institutional upper limit of normal in the presence of liver metastases)
• platelet count ≥ 100,000/µL
• absolute neutrophil count (ANC) ≥ 1500/µL
• Hgb ≥ 9.0 g/dL
• patients with previously treated brain metastases who are not on corticosteroids are eligible
• effective contraceptive method (e.g., intrauterine device, oral contraceptive, or barrier device) must be used during the study by male and female patients of childbearing potential
• ability to understand and willingness 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 study entry; study entry defined as first day of drug dosing
• patients who have undergone major surgery within 4 weeks prior to study entry
• patients who are receiving another investigational drug
• patients with active CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy
• 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 QTc prolongation and/or Torsade de Pointes
• patients with known HIV infection
• concurrent systemic hormonal therapy except: stable LHRH agonist therapy for prostate cancer; hormonal therapy (e.g., megestrol) for appetite stimulation; nasal, ophthalmic, and topical glucocorticoid preparations when appropriate; stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency; or oral contraceptives
• patients who have other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent
• pregnant or lactating women (female patients must have a negative serum pregnancy test within 7 days of study entry)
• patients who have previously received histone deacetylase inhibitors

Sponsors & Collaborators

• Pharmacyclics LLC.: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60643, United States

Location

Related Links

• Pharmacyclics

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

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

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 15, 2007
• Study Start: August 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

US (1)