Status:
COMPLETED
Study of TRC102 in Combination With Pemetrexed in Cancer Patients
Lead Sponsor:
Tracon Pharmaceuticals Inc.
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being performed to evaluate the safety and tolerability of TRC102 in combination with Alimta. In addition to safety, this study will also evaluate pharmacokinetics and tumor response.
Detailed Description
This study is being performed to evaluate the safety and tolerability of TRC102 in combination with Alimta. In addition to safety, this study will also evaluate pharmacokinetics and tumor response.
Eligibility Criteria
Inclusion
- 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 or standard therapy has failed
- The patient is at least 18 years of age
- The patient has adequate ability to perform activities of daily living
- The patient has recovered from significant toxicities of previous therapy
- The patient has adequate organ function as assessed by laboratory testing
Exclusion
- 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 drug within 4 weeks prior to first dose on this study
- The patient has had prior surgery, radiation or systemic therapy within 4 weeks of starting the study
- The patient has a history of CNS cancer
- The patient has an unstable medical condition including (not limited to) cardiac disease, HIV/AIDS, history of stroke, hepatitis or significant paricardial, pleural or peritoneal effusion
- The patient is pregnant or breastfeeding
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00692159
Start Date
June 1 2008
End Date
September 1 2010
Last Update
September 10 2010
Active Locations (3)
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1
Scottsdale, Arizona, United States, 85260
2
Santa Monica, California, United States, 90404
3
Cleveland, Ohio, United States, 44106