Study of TRC102 in Combination With Pemetrexed in Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00692159
First received: June 4, 2008
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Neoplasm
Drug: TRC102 + pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: June 2008
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose finding single arm
Drug: TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Other Name: Alimta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692159

Locations
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
Study Director: Bryan Leigh, MD Tracon Pharmaceuticals Inc.
  More Information

Additional Information:
No publications provided by Tracon Pharmaceuticals Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bryan Leigh, MD, Medical Monitor, TRACON Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00692159     History of Changes
Other Study ID Numbers: 102ST101
Study First Received: June 4, 2008
Last Updated: September 8, 2010
Health Authority: United States: Food and Drug Administration

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:
Neoplasms
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 28, 2014