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

NCT ID: NCT00582985

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

TRC105 chimeric anti-CD105 antibody

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.

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

Tracon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

TRACON Pharmaceuticals, Inc.

Principal Investigators

Bryan R Leigh, MD

Role: STUDY_DIRECTOR

Tracon Pharmaceuticals Inc.

Locations

Scottsdale, Arizona, United States

Santa Monica, California, United States

Buffalo, New York, United States

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21034418 (View on PubMed)

Other Identifiers

105ST101

Identifier Type: -

Identifier Source: org_study_id