Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
This study has been completed.
Sponsor:
Tracon Pharmaceuticals Inc.
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00492830
First received: June 25, 2007
Last updated: February 3, 2010
Last verified: February 2010
Tracking Information | |
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First Received Date ICMJE | June 25, 2007 |
Last Updated Date | February 3, 2010 |
Start Date ICMJE | June 2007 |
Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00492830 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors |
Official Title ICMJE | A Phase 1, Open-label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors |
Brief Summary | This study is being performed to evaluate the safety and tolerability of the TRC093 antibody. |
Detailed Description | In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation. |
Study Type ICMJE | Interventional |
Study Phase | Phase 1 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE | Drug: TRC093 recombinant humanized IgG1k monoclonal antibody
TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops. |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 19 |
Completion Date | November 2009 |
Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | 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:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00492830 |
Other Study ID Numbers ICMJE | 093ST101 |
Has Data Monitoring Committee | No |
Responsible Party | Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals Inc. |
Study Sponsor ICMJE | Tracon Pharmaceuticals Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Tracon Pharmaceuticals Inc. |
Verification Date | February 2010 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |