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Study of TRC102 in Combination With Pemetrexed in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692159
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
Tracon Pharmaceuticals Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasm Drug: TRC102 + pemetrexed Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Dose finding single arm
 Drug: TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Other Name: Alimta


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics [ Time Frame: Study completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692159


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85260
United States, California
Santa Monica, California, United States, 90404
United States, Ohio
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
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Study Director: Bryan Leigh, MD Tracon Pharmaceuticals Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00692159    
Other Study ID Numbers: 102ST101
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010
Keywords provided by Tracon Pharmaceuticals Inc.:
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
Additional relevant MeSH terms:
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Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors