Study of TRC102 in Combination With Pemetrexed in Cancer Patients
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ClinicalTrials.gov Identifier: NCT00692159 |
Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : September 10, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasm | Drug: TRC102 + pemetrexed | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Dose finding single arm
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Drug: TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed
Other Name: Alimta |
- 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 ]
- Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics [ Time Frame: Study completion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Bryan Leigh, MD | Tracon Pharmaceuticals Inc. |
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 |
Other Study ID Numbers: |
102ST101 |
First Posted: | June 6, 2008 Key Record Dates |
Last Update Posted: | September 10, 2010 |
Last Verified: | September 2010 |
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 |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |