Clinical trial NCT00582985: Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Neoplasm Metastasis
Keywords: Tracon
CD105
Anti CD105
TRC105
Phase 1
Cancer
Monoclonal antibody
Solid Tumor
Lead sponsor: Tracon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Safety and Tolerability will be evaluated
timeFrame: Through last patient last visit
measure: Dose Limiting Toxicities
timeFrame: 28 day evaluation period
Secondary outcomes:
measure: Pharmacokinetics of TRC105 monoclonal antibody
timeFrame: through last patient last visit
measure: Number of responses by tumor type
timeFrame: through last patient last visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Santa Monica
country: United States
state: California
city: Buffalo
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Tracon Pharmaceuticals Inc.
name: Bryan R Leigh, MD
role: STUDY_DIRECTOR
References:
citation: Seon BK, Haba A, Matsuno F, Takahashi N, Tsujie M, She X, Harada N, Uneda S, Tsujie T, Toi H, Tsai H, Haruta Y. Endoglin-targeted cancer therapy. Curr Drug Deliv. 2011 Jan;8(1):135-43. doi: 10.2174/156720111793663570.