Clinical trial NCT00692159: Study of TRC102 in Combination With Pemetrexed in Cancer Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
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
Lead sponsor: Tracon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Study completion
Secondary outcomes:
measure: Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics
timeFrame: Study completion
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Santa Monica
country: United States
state: California
city: Cleveland
country: United States
state: Ohio
Study officials:
affiliation: Tracon Pharmaceuticals Inc.
name: Bryan Leigh, MD
role: STUDY_DIRECTOR
References:
citation: Gordon MS, Rosen LS, Mendelson D, Ramanathan RK, Goldman J, Liu L, Xu Y, Gerson SL, Anthony SP, Figg WD, Spencer S, Adams BJ, Theuer CP, Leigh BR, Weiss GJ. A phase 1 study of TRC102, an inhibitor of base excision repair, and pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):714-23. doi: 10.1007/s10637-012-9876-9. Epub 2012 Sep 29.