Trial of AVN-944 in Patients With Advanced Hematologic Malignancies

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273936
• Other study ID #: AVN-944-002
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2006
• Last updated: August 2, 2011
• Start date: January 2006

Study information

• Verified date: August 2011
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• AVN-944 capsules for oral administration

Locations

Country	Name	City	State
United States	Ohio State University, James Cancer Hospital Comprehensive Cancer Center	Columbus	Ohio
United States	Oregon Health and Science University	Portland	Oregon
United States	Stanford Cancer Center	Stanford	California
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States,