NCT00273936

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

First QC Date

January 6, 2006

Last Update Submit

August 2, 2011

Conditions

Acute LeukemiaChronic LeukemiaMultiple MyelomaHodgkin's LymphomaNon-Hodgkin's LymphomaWaldenstrom's Macroglobulinemia

Interventions

AVN-944 capsules for oral administrationDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients must be refractory to, intolerant of, or decline to receive established therapy known to provide clinical benefit for their condition.
  • Age \> 18 years
  • ECOG performance score of 0 or 1
  • Adequate renal function as evidenced by serum creatinine \< 2.0 mg/dL
  • 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
  • Patients must be recovered from the clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy.
  • Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
  • 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).

You may not qualify if:

  • Patients with an uncontrolled active infection
  • Prior treatment with an inosine-5-monophosphate dehydrogenase (IMPDH)-inhibitor
  • 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.
  • Patients with known hypersensitivity to any of the components of AVN-944
  • 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.
  • Grade 2 peripheral neuropathy
  • Patients who are pregnant or lactating
  • 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.
  • History of solid organ transplant
  • Known HIV or hepatitis B or C (active, previously treated or both)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Ohio State University, James Cancer Hospital Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 097239, United States

Location

MeSH Terms

Conditions

Multiple MyelomaHodgkin DiseaseLymphoma, Non-HodgkinWaldenstrom Macroglobulinemia

Interventions

AVN 944

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 10, 2006

Study Start

January 1, 2006

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(5)