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A Phase I Trial of AVN-944 in Patients With Advanced Hematologic Malignancies

Phase 1
18 Years
Not Enrolling
Acute Leukemia, Chronic Leukemia, Multiple Myeloma, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Waldenstrom's Macroglobulinemia

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Trial Information

A Phase I Trial of AVN-944 in Patients With Advanced Hematologic Malignancies

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Acute Leukemia
  • Chronic Leukemia
  • Multiple Myeloma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Waldenstrom's Macroglobulinemia
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms
  • Chronic Disease



Stanford Cancer Center Stanford, California  94305-5824
Arizona Clinical Research Center Tucson, Arizona  85712
George Washington University Washington, District of Columbia  20037
Oregon Health and Science University Portland, Oregon  97201
Ohio State University, James Cancer Hospital Comprehensive Cancer Center Columbus, Ohio  43210