Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer
This study has been completed.
Sponsor:
Tracon Pharmaceuticals Inc.
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00582985
First received: December 19, 2007
Last updated: March 2, 2012
Last verified: March 2012
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Purpose
This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Neoplasm Metastasis |
Drug: TRC105 chimeric anti-CD105 antibody |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Tracon Pharmaceuticals Inc.:
Primary Outcome Measures:
- Safety and Tolerability will be evaluated [ Time Frame: Through last patient last visit ] [ Designated as safety issue: Yes ]
- Dose Limiting Toxicities [ Time Frame: 28 day evaluation period ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics of TRC105 monoclonal antibody [ Time Frame: through last patient last visit ] [ Designated as safety issue: No ]
- Number of responses by tumor type [ Time Frame: through last patient last visit ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582985
Locations
| United States, Arizona | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, California | |
| Santa Monica, California, United States, 90404 | |
| United States, New York | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27705 | |
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
| Study Director: | Bryan R Leigh, MD | Tracon Pharmaceuticals Inc. |
More Information
No publications provided by Tracon Pharmaceuticals Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00582985 History of Changes |
| Other Study ID Numbers: | 105ST101 |
| Study First Received: | December 19, 2007 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tracon Pharmaceuticals Inc.:
|
Tracon CD105 Anti CD105 TRC105 |
Phase 1 Cancer Monoclonal antibody Solid Tumor |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Antibodies |
Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013