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

NCT00492830 | Completed Phase 1

• 1 other identifier: 093ST101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.

Conditions

Cancer; Neoplasm Metastasis

Keywords

Phase 1; TRC093; denatured collagen; solid tumor; antibody; TRACON; Locally advanced solid tumors; Metastatic solid tumors

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability will be evaluated

  Through last patient last visit

• Dose Limiting Toxicities

  28 day evaluation period

Secondary Outcomes (2)

• Pharmacokinetics of TRC093 monoclonal antibody

  Through last patient last visit

• Number of responses by tumor type

  Through last patient last visit

Interventions

TRC093 recombinant humanized IgG1k monoclonal antibody DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient will be eligible for study participation only if all of the following criteria apply:
• The patient has given informed consent.
• The patient is willing and able to abide by the protocol.
• The patient is at least 18 years old.
• The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
• Significant toxicities resulting from prior therapy must have recovered.
• If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
• If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
• The patient has adequate ability to perform activities of daily living.
• The patient has adequate organ function as assessed by laboratory tests

You may not qualify if:

• A patient will not be eligible for study participation if any of the following criteria apply:
• The patient weighs more than 264 lbs.
• 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.
• The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
• The patient has known brain tumors.
• The patient experienced blood clots within six months prior to study start.
• The patient has a non-healing wound, ulcer or bone fracture.
• The patient received recent thrombolytic or anticoagulant therapy.
• 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.
• The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
• 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.

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (3)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

US (3)