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Trial of AVN-944 in Patients With Advanced Hematologic Malignancies
This study has been completed.

First Received on January 6, 2006.   Last Updated on August 2, 2011   History of Changes
Sponsor: Vertex Pharmaceuticals Incorporated
Information provided by: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00273936
  Purpose

The purpose of this study is to determine the safety and maximum tolerated dose, pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced hematologic malignancies.


Condition Intervention Phase
Acute Leukemia
Chronic Leukemia
Multiple Myeloma
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Waldenstrom's Macroglobulinemia
Drug: AVN-944 capsules for oral administration
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I Trial of AVN-944 in Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Estimated Enrollment: 72
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed chronic myelogenous leukemia, acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma or Hodgkin's disease.
  2. Patients must be refractory to, intolerant of, or decline to receive established therapy known to provide clinical benefit for their condition.
  3. Age > 18 years
  4. ECOG performance score of 0 or 1
  5. Adequate renal function as evidenced by serum creatinine < 2.0 mg/dL
  6. Adequate hepatic function as evidenced by:

    • Serum total bilirubin < 2.0 mg/dL (Patients with known Gilbert's syndrome may have total bilirubin values of up to 3 mg/dL.)
    • Alkaline phosphatase < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN if considered related to underlying disease)
    • SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN if considered related to underlying disease
  7. Patients must be recovered from the clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy.
  8. Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
  9. Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method).

Exclusion Criteria:

  1. Patients with an uncontrolled active infection
  2. Prior treatment with an inosine-5-monophosphate dehydrogenase (IMPDH)-inhibitor
  3. History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL Patients with other curatively treated malignancies who have no evidence of metastatic disease may be entered after discussion with the Medical Monitor.
  4. Patients with known hypersensitivity to any of the components of AVN-944
  5. Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade 2.
  6. Grade 2 peripheral neuropathy
  7. Patients who are pregnant or lactating
  8. Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  9. History of solid organ transplant
  10. Known HIV or hepatitis B or C (active, previously treated or both)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273936

Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Ohio
Ohio State University, James Cancer Hospital Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 097239
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273936     History of Changes
Other Study ID Numbers: AVN-944-002
Study First Received: January 6, 2006
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Multiple Myeloma
Neoplasms, Plasma Cell
Acute Disease
Hematologic Neoplasms
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Disease Attributes
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2012