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Sponsored by: |
Tracon Pharmaceuticals Inc. |
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Information provided by: | Tracon Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00582985 |
This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.
Condition | Intervention | Phase |
---|---|---|
Cancer Neoplasm Metastasis |
Drug: TRC105 chimeric anti-CD105 antibody |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable |
Estimated Enrollment: | 22 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bonne Adams, MBA | 858-550-0780 ext 232 | badams@traconpharma.com |
Contact: Charles Theuer, MD, PhD | 858-550-0780 ext 233 | ctheuer@traconpharma.com |
United States, Arizona | |
Recruiting | |
Scottsdale, Arizona, United States, 85260 | |
United States, California | |
Recruiting | |
Santa Monica, California, United States, 90404 | |
United States, New York | |
Recruiting | |
Buffalo, New York, United States, 14263 | |
United States, North Carolina | |
Recruiting | |
Durham, North Carolina, United States, 27705 |
Responsible Party: | TRACON Pharmaceuticals, Inc. ( Charles P. Theuer, PhD, MD, Medical Monitor ) |
Study ID Numbers: | 105ST101 |
Study First Received: | December 19, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00582985 |
Health Authority: | United States: Food and Drug Administration |
Tracon CD105 Anti CD105 TRC105 |
Phase 1 Cancer Monoclonal antibody Solid Tumor |
Antibodies, Monoclonal Signs and Symptoms Antibodies Neoplasm Metastasis Immunoglobulins |
Neoplasms Neoplastic Processes Pathologic Processes |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |