Study of TRC102 in Combination With Pemetrexed in Cancer Patients

September 8, 2010 updated by: Tracon Pharmaceuticals Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
    • California
      • Santa Monica, California, United States, 90404
    • Ohio
      • Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dose finding single arm
Drug: TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Other Names:
  • Alimta

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Study completion
Study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics
Time Frame: Study completion
Study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tracon Pharmaceuticals Inc.

Investigators

  • Study Director: Bryan Leigh, MD, Tracon Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 10, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102ST101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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