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Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

Phase 1
18 Years
Not Enrolling
Hematologic Neoplasms, Neoplasms

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Trial Information

Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

Patients will receive a single oral dose of CRA-024781 one week before beginning intravenous
dosing. Blood samples for pharmacokinetic and pharmacodynamic analysis will be collected on
several occasions prior to the start of the intravenous treatment.

The intravenous treatment will consist of 3 consecutive days of CRA-024781 IV administered
as a 2-hour IV infusion every 3 weeks in a 4 weeks cycle.

Assessment of the extent of disease will be performed every 8 weeks.

Inclusion Criteria:

- 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

- 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

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Samir Undevia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:

PCYC 0401



Start Date:

August 2005

Completion Date:

December 2007

Related Keywords:

  • Hematologic Neoplasms
  • Neoplasms
  • Neoplasms
  • Hematologic Neoplasms



University of Chicago Chicago, Illinois  60637