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

NCT02354612 | Unknown

• 1 other identifier: 105CON101
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, continuation study

Conditions

Solid Tumors

Interventions

TRC105 DRUG

Also known as: Chimeric Antibody (TRC105) to CD105

Bevacizumab DRUG

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

Also known as: Avastin

Axitinib DRUG

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

Also known as: Inlyta

Pazopanib DRUG

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

Also known as: Votrient

Capecitabine DRUG

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

Also known as: Xeloda

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (1)

UCLA

Santa Monica, California, 90404, United States

Location

MeSH Terms

Interventions

carotuximab; Bevacizumab; Axitinib; pazopanib; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Charles Theuer, MD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 3, 2015
• Last Updated: February 15, 2021

Record last verified: 2021-01

Locations

US (1)