Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Study Overview
=================
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.

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

Conditions
-----------------
Neoplasm

Intervention / Treatment
-----------------
* Drug: TRC102 + pemetrexed


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose finding single arm | Drug: TRC102 + pemetrexed<br>* Oral TRC102 solution + IV pemetrexed<br>* Other names: Alimta;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics |  | Study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRC102, Methoxyamine HCL, Pemetrexed, Alimta, Tracon, Phase 1, Cancer, BER, Base Excision Repair, Small Molecule, Anti-folate, Solid Tumor, Neoplastic Processes, Pathologic Processes, Pathological Conditions, Signs and Symptoms