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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492830
• Other study ID #: 093ST101
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2007
• Last updated: February 3, 2010
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: February 2010
• Source: Tracon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tracon Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability will be evaluated		Through last patient last visit	Yes
Primary	Dose Limiting Toxicities		28 day evaluation period	Yes
Secondary	Pharmacokinetics of TRC093 monoclonal antibody		Through last patient last visit	No
Secondary	Number of responses by tumor type		Through last patient last visit	No