Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

Phase 1

Completed

• Conditions: Cancer; Neoplasm Metastasis

• Registration Number: NCT00582985
• Lead Sponsor: Tracon Pharmaceuticals Inc.

Brief Summary

This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.

Detailed Description

In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• The patient has given informed consent.
• The patient is willing and able to abide by the protocol.
• The patient has cancer and curative therapy is unavailable.
• The patient is at least 18 years old.
• The patient has adequate ability to perform activities of daily living.
• Significant toxicities from prior therapy must have recovered.
• The patient has adequate organ function as assessed by laboratory test.

Exclusion Criteria

• The patient weighs more than 264 lbs.
• The patient has a known allergy to gentamicin
• The patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue
• The patient is currently on treatment on another therapeutic clinical trial or has received an investigational agent within 4 weeks prior to first dose with study drug
• The patient has had prior surgery (including open biopsy), radiation therapy or systemic therapy within 4 weeks of starting the study treatment
• The patient has hypertension > 160/90
• The patient has a history of CNS cancer
• The patient has an unstable medical condition including, but not limited to, cardiac disease, history of stroke, active hepatitis, or significant pericardial, pleural or peritoneal effusion
• The patient received recent thrombolytic or anticoagulant therapy
• The patient has lung cancer with central chest lesions
• The patient has had hemorrhage or unhealed wounds within 30 days of dosing
• The patient has used systemic corticosteroids within 3 months of dosing
• The patient has known HIV/AIDS
• The patient has a history of hypersensitivity reaction to human or mouse antibody products
• The patient is pregnant or breastfeeding.
• The patient has a history of peptic ulcer disease or gastritis within 6 months of dosing, unless complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 30 days of dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability will be evaluated	Through last patient last visit
Dose Limiting Toxicities	28 day evaluation period

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of TRC105 monoclonal antibody	through last patient last visit
Number of responses by tumor type	through last patient last visit