- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273936
Trial of AVN-944 in Patients With Advanced Hematologic Malignancies
August 2, 2011 updated by: Vertex Pharmaceuticals Incorporated
A Phase I Trial of AVN-944 in Patients With Advanced Hematologic Malignancies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85715
- Arizona Clinical Research Center
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California
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Stanford, California, United States, 94305
- Stanford Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University, James Cancer Hospital Comprehensive Cancer Center
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Oregon
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Portland, Oregon, United States, 097239
- Oregon Health and Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Registration Dates
First Submitted
January 6, 2006
First Submitted That Met QC Criteria
January 6, 2006
First Posted (Estimate)
January 10, 2006
Study Record Updates
Last Update Posted (Estimate)
August 4, 2011
Last Update Submitted That Met QC Criteria
August 2, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Hematologic Neoplasms
- Multiple Myeloma
- Leukemia
- Waldenstrom Macroglobulinemia
Other Study ID Numbers
- AVN-944-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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