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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582985
• Other study ID #: 105ST101
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2007
• Last updated: March 2, 2012
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: Tracon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tracon Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability will be evaluated		Through last patient last visit	Yes
Primary	Dose Limiting Toxicities		28 day evaluation period	Yes
Secondary	Pharmacokinetics of TRC105 monoclonal antibody		through last patient last visit	No
Secondary	Number of responses by tumor type		through last patient last visit	No