Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Sponsor

Tracon Pharmaceuticals Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00692159

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Drug: TRC102 + pemetrexed	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Label Phase 1 Dose Finding Study of TRC102 in Combination With Pemetrexed in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose finding single arm	Drug: TRC102 + pemetrexed Oral TRC102 solution + IV pemetrexed Other Names: Alimta

Arm

Intervention/Treatment

Experimental: 1

Dose finding single arm

Drug: TRC102 + pemetrexed

Oral TRC102 solution + IV pemetrexed

Other Names:

Alimta

Outcome Measures

Primary Outcome Measures

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

Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics [Study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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