Neoplasm
Conditions
Keywords
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
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.
Interventions
DRUGTRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Sponsors
Tracon Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics | Study completion |
Countries
United States
Outcome results
None listed