Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer

NCT01326481 | Completed Phase 1 Results DMC

• 1 other identifier: 105BC102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

TRC105; Breast Cancer; CD105; Endoglin; TRACON Pharma; Roswell Park Cancer Institute; Department of Defense

Outcome Measures

Primary Outcomes (1)

• Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine

  Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.

  1.5 years

Secondary Outcomes (3)

• TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D

  Cycle 2 day 1 (3 weeks)

• Number of Patients With Positive Immune Response to TRC105

  1.5 years

• Number of Patients With Objective Response According to RECIST 1.1

  1.5 years

Study Arms (1)

Single

EXPERIMENTAL

All patients received TRC105 + capecitabine

Drug: TRC105; Drug: Capecitabine

Interventions

TRC105 DRUG

IV

Also known as: carotuximab

Single

Capecitabine DRUG

oral

Also known as: xeloda

Single

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)
• Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)
• Measurable disease by RECIST 1.1 criteria (Part 2 only)
• Willing and able to consent for self to participate in study
• Progressive or recurrent disease after prior systemic chemotherapy regimen
• Age ≥ 18 years
• ECOG performance status of 0 or 1
• Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
• Adequate organ function

You may not qualify if:

• Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.
• Prior treatment with TRC105
• History of hypersensitivity reaction to antimetabolite therapy
• Receipt of an investigational agent within 28 days of starting study treatment
• Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment
• Minor surgical procedures within 14 days prior to first dose of TRC105
• History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
• Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months
• Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy
• Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia
• Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105
• Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last month
• Hemorrhage within 28 days of starting study treatment
• Unhealed wounds within 28 days of starting study treatment
• History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead
• Roswell Park Cancer Institute: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

carotuximab; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Charles Theuer, Medical Monitor
• Organization: TRACON Pharmaceuticals Inc

ctheuer@traconpharma.com

8585500780

Study Officials

• Charles Theuer, MD PhD

  Tracon Pharmaceuticals Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 31, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Locations

US (2)