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

Primary Purpose

Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRC105 chimeric anti-CD105 antibody
Sponsored by
Tracon Pharmaceuticals Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Tracon, CD105, Anti CD105, TRC105, Phase 1, Cancer, Monoclonal antibody, Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Safety and Tolerability will be evaluated
Dose Limiting Toxicities

Secondary Outcome Measures

Pharmacokinetics of TRC105 monoclonal antibody
Number of responses by tumor type

Full Information

First Posted
December 19, 2007
Last Updated
March 2, 2012
Sponsor
Tracon Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00582985
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tracon Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Neoplasm Metastasis
Keywords
Tracon, CD105, Anti CD105, TRC105, Phase 1, Cancer, Monoclonal antibody, Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TRC105 chimeric anti-CD105 antibody
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and Tolerability will be evaluated
Time Frame
Through last patient last visit
Title
Dose Limiting Toxicities
Time Frame
28 day evaluation period
Secondary Outcome Measure Information:
Title
Pharmacokinetics of TRC105 monoclonal antibody
Time Frame
through last patient last visit
Title
Number of responses by tumor type
Time Frame
through last patient last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan R Leigh, MD
Organizational Affiliation
Tracon Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21034418
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.
Results Reference
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Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

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