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OpenTrials
Completed

NCT Number: NCT00692159

Study of TRC102 in Combination With Pemetrexed in Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRC102 + pemetrexed

Drug

Oral TRC102 solution + IV pemetrexed

Other names: Alimta

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.

    Time frame: Study completion

Secondary outcomes

  1. Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics

    Time frame: Study completion

Sponsors and collaborators

Lead sponsor

Tracon Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 6, 2008
Registry last updated
Sep 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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