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Sponsored by: |
AVEO Pharmaceuticals, Inc. |
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Information provided by: | AVEO Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00551850 |
The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase, with added activity against Her2 and other oncogenic kinases. Based on evidence of preclinical activity in various solid tumors, AV-412 is being developed as a possible novel treatment for cancer in humans.
PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and determine the maximum tolerated dose of AV-412 when administered orally three times weekly.
Condition | Intervention | Phase |
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Advanced Cancer Refractory Cancer |
Drug: AV-412 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Multi-Center, Dose-Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of AV-412 Administered Orally Three Times Weekly to Subjects With Advanced Solid Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AV-412
oral solid dosage form administered three times weekly for 4 weeks (1 cycle)
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This is an open-label, dose escalation trial, and all subjects will receive oral AV-412 administered three times weekly for 4 weeks (1 cycle) to evaluate safety and tolerability of AV-412. Treatment duration will be a minimum of 2 consecutive dosing cycles (8 weeks), if tolerated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects enrolled in the MTD Cohort B must have the following:
Exclusion Criteria:
Active second malignancy or history of another malignancy within 2 years with the exception of:
Any of the following hematologic abnormalities:
Any of the following serum chemistry abnormalities:
Significant cardiovascular disease or condition, including:
Significant gastrointestinal abnormalities, including:
Known history of significant ophthalmologic abnormalities, including:
Drugs and Treatments to be Excluded:
Any prior therapy with the following:
Therapy within 2 weeks prior to administration of the first dose or at any time during the study with:
• Herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
Therapy within 3 weeks prior to administration of the first dose or at any time during the study with:
Therapy within 4 weeks prior to administration of the first dose or at any time during the study with:
Systemic hormonal therapy within 4 weeks prior to administration of the first dose or at any time during the study, with the exception of the following allowed therapies:
Radiotherapy for the primary malignancy:
United States, District of Columbia | |
Georgetown University Hospital | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Karen Dorsch-Vogel 202-687-6974 kd252@georgetown.edu | |
Principal Investigator: Jimmy Hwang, M.D. | |
United States, Kansas | |
Kansas Masonic Cancer Research Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Cinda Lyon 913-588-2567 clyon@kumc.edu | |
Principal Investigator: Karen Kelly, M.D. | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Andrew Wolanski, NP 617-632-6623 andrew.wolanski@dfci.harvard.edu | |
Principal Investigator: Kwok-Kin Wong, M.D. | |
United States, New York | |
Montefiore Medical Center | Recruiting |
New York City, New York, United States, 10461 | |
Contact: Mohammad H Ghalib 718-405-8515 mhghalib@montefiore.org | |
Principal Investigator: Sridhar Mani, M.D. |
Study Director: | Pankaj Bhargava, M.D. | AVEO Pharmaceuticals |
Responsible Party: | AVEO Pharmaceuticals ( David Graham/Sr. Director, Program Management ) |
Study ID Numbers: | AV-412-07-102 |
Study First Received: | October 30, 2007 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00551850 |
Health Authority: | United States: Food and Drug Administration |
epidermal growth factor inhibitor solid tumors advanced cancer |