Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Tracon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Drug: TRC102 + pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692159

102ST101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

1

Experimental group

Description:

Dose finding single arm

Treatment:

Drug: TRC102 + pemetrexed