A Phase I Trial of AVN944, an IMPDH Inhibitor, in Adults With Advanced Stage Solid Tumors

Withdrawn before enrolling · Not applicable

Conditions studied: Refractory Solid Tumors

In brief

Background: * AVN944 is an experimental cancer treatment drug, not yet approved by the U.S. Food and Drug Administration. To date, AVN944 as a single drug has been tested in several studies involving humans, including healthy volunteers, patients with leukemia, and patients with advanced pancreatic cancer. * More research is needed to determine the safety and effectiveness of AVN944. Objectives: * To determine the safety of AVN944. * To determine the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) of AVN944. * To see if AVN944 has any effect on patients' tumors. * To learn how the body breaks down AVN944. Eligibility: * Patients 18 years of age and older who have advanced stage solid tumors for which standard therapies do not exist or are no longer effective. Design: * Participants will have a screening visit and five clinic visits during the first treatment cycle. Additional treatment cycles will involve two clinic visits during each 28-day cycle. After participation in the study ends, patients will be asked to return within 28 days after the last dose of study drug for final study procedures. * Evaluations before the treatment period: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Questions about medications and side effects. * Blood and urine tests. * Disease evaluation with CT, chest x-ray, and additional laboratory tests depending on the type of cancer. * All patients will have blood samples taken at each visit. * Patients will take specific doses of AVN994 as directed by researchers, and will be asked to keep a diary to record their doses and any side effects. They will be monitored with frequent blood draws at each study visit to provide information on the safety and effectiveness of the drug. * During different cycles, patients will have their disease evaluated by researchers and will be asked if they wish to continue taking AVN994 as part of the study.

Key facts

Study ID

NCT00923728

Run by

Vertex Pharmaceuticals Incorporated

People needed

0

Starts

2009-04-01

Expected to finish

2010-03-01

Last updated by the study team

2014-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 less than Grade 2.
• Patients with known active brain metastases or other CNS involvement with less than 6 months since curative-intent treatment
• Patients receiving growth factors
• Prior treatment with an IMPDH-inhibitor e.g. Mycophenolate Mofetil, \& Tiazofurin
• Uncontrolled current illness requiring hospitalization or intravenous antibiotics within the past 7 days
• Pregnant women are excluded from this study because AVN944 agent has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AVN944, breastfeeding should be discontinued if the mother is treated with AVN944.
• History of solid organ transplant and are on IMPDH inhibitors (mycophenolate mofetil) therapy
• HIV-positive patients
• The following medications and/or treatments are not permitted during the trial (i.e., through completion of the post treatment follow-up) and would constitute exclusion from the protocol:
• Any other investigational treatment
• Any cytotoxic chemotherapy
• Any other systemic anti-neoplastic therapy including, but not limited to, immunotherapy or monoclonal antibody therapy.
• Any radiotherapy, including systemically administered radioisotopes.
• Systemic corticosteroids.
• Any hormonal therapy except GnRH agonists / antagonists for patients with prostate cancer or medroxyprogesterone
• Growth factors

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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