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Phase 1, Open-Label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by Tracon Pharmaceuticals Inc., September 2008
Sponsored by: Tracon Pharmaceuticals Inc.
Information provided by: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00492830
  Purpose

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

MedlinePlus related topics: Cancer
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
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

Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety and tolerability will be evaluated [ Time Frame: Through last patient last visit ] [ Designated as safety issue: Yes ]
  • Dose Limiting Toxicities [ Time Frame: 28 day evaluation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of TRC093 monoclonal antibody [ Time Frame: Through last patient last visit ] [ Designated as safety issue: No ]
  • Number of responses by tumor type [ Time Frame: Through last patient last visit ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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.
Detailed Description:

In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for study participation only if all of the following criteria apply:

  1. The patient has given informed consent.
  2. The patient is willing and able to abide by the protocol.
  3. The patient is at least 18 years old.
  4. The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
  5. Significant toxicities resulting from prior therapy must have recovered.
  6. If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
  7. If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
  8. The patient has adequate ability to perform activities of daily living.
  9. The patient has adequate organ function as assessed by laboratory tests

Exclusion Criteria:

A patient will not be eligible for study participation if any of the following criteria apply:

  1. The patient weighs more than 264 lbs.
  2. The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
  3. The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
  4. The patient has known brain tumors.
  5. The patient experienced blood clots within six months prior to study start.
  6. The patient has a non-healing wound, ulcer or bone fracture.
  7. The patient received recent thrombolytic or anticoagulant therapy.
  8. The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
  9. The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
  10. The patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (LHRH) agonists.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492830

Contacts
Contact: Bonne Adams 858-550-0780
Contact: Charles Theuer 858-550-0780

Locations
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
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
  More Information

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

Keywords provided by Tracon Pharmaceuticals Inc.:
Phase 1
TRC093
denatured collagen
solid tumor
antibody
TRACON
Locally advanced solid tumors
Metastatic solid tumors

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Neoplasm Metastasis
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009