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

NCT00582985 | Completed Phase 1

• 1 other identifier: 105ST101
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cancer; Neoplasm Metastasis

Keywords

Tracon; CD105; Anti CD105; TRC105; Phase 1; Cancer; Monoclonal antibody; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability will be evaluated

  Through last patient last visit

• Dose Limiting Toxicities

  28 day evaluation period

Secondary Outcomes (2)

• Pharmacokinetics of TRC105 monoclonal antibody

  through last patient last visit

• Number of responses by tumor type

  through last patient last visit

Interventions

TRC105 chimeric anti-CD105 antibody DRUG

TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (4)

Unknown Facility

Scottsdale, Arizona, 85260, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Buffalo, New York, 14263, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Seon BK, Haba A, Matsuno F, Takahashi N, Tsujie M, She X, Harada N, Uneda S, Tsujie T, Toi H, Tsai H, Haruta Y. Endoglin-targeted cancer therapy. Curr Drug Deliv. 2011 Jan;8(1):135-43. doi: 10.2174/156720111793663570.

  PMID: 21034418 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryan R Leigh, MD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

US (4)