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

Sponsor

Tracon Pharmaceuticals Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00582985

Collaborator

(none)

Enrollment

Locations

Duration (Months)

12.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2007

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

Safety and Tolerability will be evaluated [Through last patient last visit]
Dose Limiting Toxicities [28 day evaluation period]

Secondary Outcome Measures

Pharmacokinetics of TRC105 monoclonal antibody [through last patient last visit]
Number of responses by tumor type [through last patient last visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Scottsdale	Arizona	United States	85260
2	Santa Monica	California	United States	90404
3	Buffalo	New York	United States	14263
4	Durham	North Carolina	United States	27705