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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582985
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : March 5, 2012
Information provided by:
Tracon Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Cancer Neoplasm Metastasis Drug: TRC105 chimeric anti-CD105 antibody Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable
Study Start Date : December 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: 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.

Primary Outcome Measures :
  1. Safety and Tolerability will be evaluated [ Time Frame: Through last patient last visit ]
  2. Dose Limiting Toxicities [ Time Frame: 28 day evaluation period ]

Secondary Outcome Measures :
  1. Pharmacokinetics of TRC105 monoclonal antibody [ Time Frame: through last patient last visit ]
  2. Number of responses by tumor type [ Time Frame: through last patient last visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582985

United States, Arizona
Scottsdale, Arizona, United States, 85260
United States, California
Santa Monica, California, United States, 90404
United States, New York
Buffalo, New York, United States, 14263
United States, North Carolina
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Study Director: Bryan R Leigh, MD Tracon Pharmaceuticals Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals, Inc. Identifier: NCT00582985     History of Changes
Other Study ID Numbers: 105ST101
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Tracon Pharmaceuticals Inc.:
Anti CD105
Phase 1
Monoclonal antibody
Solid Tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs