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Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00492830
First received: June 25, 2007
Last updated: February 3, 2010
Last verified: February 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 19
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492830

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Santa Monica, California, United States
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00492830     History of Changes
Other Study ID Numbers: 093ST101
Study First Received: June 25, 2007
Last Updated: February 3, 2010
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014