Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: TRC102 + pemetrexed

• Registration Number: NCT00692159
• Lead Sponsor: Tracon Pharmaceuticals Inc.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2010-06
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TRC102 + pemetrexed	Dose finding single arm

Primary Outcome Measures

Name	Time	Method
To determine the recommended Phase 2 dose and overall safety and tolerability of TRC102 when given alone and when combined with pemetrexed for the treatment of patients with advanced solid or metastatic cancer for whom curative therapy is unavailable.	Study completion

Secondary Outcome Measures

Name	Time	Method
Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics	Study completion