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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.

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date September 10, 2010
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics [ Time Frame: Study completion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TRC102 in Combination With Pemetrexed in Cancer Patients
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm
Intervention  ICMJE Drug: TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Other Name: Alimta
Study Arms  ICMJE Experimental: 1
Dose finding single arm
Intervention: Drug: TRC102 + pemetrexed
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2010)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2008)
30
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00692159
Other Study ID Numbers  ICMJE 102ST101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals Inc.
Study Sponsor  ICMJE Tracon Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bryan Leigh, MD Tracon Pharmaceuticals Inc.
PRS Account Tracon Pharmaceuticals Inc.
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP