Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial

NCT ID: NCT02354612

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

Open-label, continuation study

Detailed Description

This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have completed a previous TRC105 study and are judged by the investigator to have the potential to benefit from continued TRC105 therapy.

Conditions

Solid Tumors

Interventions

TRC105

Intervention Type: DRUG

Bevacizumab

companion therapy selection depends on companion therapy used in the parent study

Intervention Type: DRUG

Axitinib

companion therapy selection depends on companion therapy used in the parent study

Intervention Type: DRUG

Pazopanib

companion therapy selection depends on companion therapy used in the parent study

Intervention Type: DRUG

Capecitabine

companion therapy selection depends on companion therapy used in the parent study

Intervention Type: DRUG

Other Intervention Names

Chimeric Antibody (TRC105) to CD105; Avastin; Inlyta; Votrient; Xeloda

Eligibility Criteria

Inclusion Criteria

• Participation in a TRACON Pharmaceuticals sponsored parent TRC105 study and, thought to have potential to derive clinical benefit from continued treatment with TRC105 in the opinion of the parent study investigator.
• Willing and able to consent for self to participate in study
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• 18 years of age or older
• ability to begin TRC105 dosing on this protocol within 6 weeks from the subjects last dose of TRC105 in the parent TRC105 study

Exclusion Criteria

• Any clinical event that would make TRC105 therapy inappropriate under the parent protocol
• Current treatment in another clinical study
• Pregnant or breastfeeding
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tracon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Theuer, MD

Role: STUDY_DIRECTOR

Tracon Pharmaceuticals Inc.

Locations

UCLA

Santa Monica, California, United States

Countries

United States

Other Identifiers

105CON101

Identifier Type: -

Identifier Source: org_study_id