Study of TRC102 in Combination With Pemetrexed in Cancer Patients

NCT00692159 | Completed Phase 1

• 1 other identifier: 102ST101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics

  Study completion

Study Arms (1)

1

EXPERIMENTAL

Dose finding single arm

Drug: TRC102 + pemetrexed

Interventions

TRC102 + pemetrexed DRUG

Oral TRC102 solution + IV pemetrexed

Also known as: Alimta

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (3)

Unknown Facility

Scottsdale, Arizona, 85260, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 23054206 DERIVED

Related Links

• TRACON Pharmaceuticals Inc. Web Site

MeSH Terms

Conditions

Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Bryan Leigh, MD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 10, 2010

Record last verified: 2010-09

Locations

US (3)