Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Tracon Pharmaceuticals Inc. |
---|---|
Information provided by: | Tracon Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00492830 |
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
Condition | Intervention | Phase |
---|---|---|
Cancer Neoplasm Metastasis |
Drug: TRC093 recombinant humanized IgG1k monoclonal antibody |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Open-Label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | June 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-TRC093 antibody formation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient will be eligible for study participation only if all of the following criteria apply:
Exclusion Criteria:
A patient will not be eligible for study participation if any of the following criteria apply:
Contact: Bonne Adams | 858-550-0780 | |
Contact: Charles Theuer | 858-550-0780 |
United States, Alabama | |
Recruiting | |
Birmingham, Alabama, United States | |
United States, Arizona | |
Completed | |
Phoenix, Arizona, United States | |
United States, California | |
Completed | |
Santa Monica, California, United States |
Responsible Party: | TRACON Pharmaceuticals Inc. ( Charles P. Theuer, PhD, MD, Medical Monitor ) |
Study ID Numbers: | 093ST101 |
Study First Received: | June 25, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00492830 |
Health Authority: | United States: Food and Drug Administration |
Phase 1 TRC093 denatured collagen solid tumor |
antibody TRACON Locally advanced solid tumors Metastatic solid tumors |
Antibodies, Monoclonal Antibodies Neoplasm Metastasis Immunoglobulins |
Neoplasms Neoplastic Processes Pathologic Processes |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |