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An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Neoplasm Metastasis

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Trial Information

An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability will be evaluated

Outcome Time Frame:

Through last patient last visit

Safety Issue:

Yes

Principal Investigator

Bryan R Leigh, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tracon Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

105ST101

NCT ID:

NCT00582985

Start Date:

December 2007

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • Neoplasm Metastasis
  • Tracon
  • CD105
  • Anti CD105
  • TRC105
  • Phase 1
  • Cancer
  • Monoclonal antibody
  • Solid Tumor
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Charlotte, North Carolina