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

This study has been completed.
Sponsor:
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00582985
First received: December 19, 2007
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Cancer
Neoplasm Metastasis
Drug: TRC105 chimeric anti-CD105 antibody
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety and Tolerability will be evaluated [ Time Frame: Through last patient last visit ] [ Designated as safety issue: Yes ]
  • Dose Limiting Toxicities [ Time Frame: 28 day evaluation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of TRC105 monoclonal antibody [ Time Frame: through last patient last visit ] [ Designated as safety issue: No ]
  • Number of responses by tumor type [ Time Frame: through last patient last visit ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582985

Locations
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.
Investigators
Study Director: Bryan R Leigh, MD Tracon Pharmaceuticals Inc.
  More Information

No publications provided by Tracon Pharmaceuticals Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00582985     History of Changes
Other Study ID Numbers: 105ST101
Study First Received: December 19, 2007
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tracon Pharmaceuticals Inc.:
Tracon
CD105
Anti CD105
TRC105
Phase 1
Cancer
Monoclonal antibody
Solid Tumor

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014