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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

Study completion

Safety Issue:

Yes

Principal Investigator

Bryan Leigh, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tracon Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

102ST101

NCT ID:

NCT00692159

Start Date:

June 2008

Completion Date:

September 2010

Related Keywords:

  • Neoplasm
  • 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
  • Neoplasms

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Cleveland, Ohio  44195