Study of TRC102 in Combination With Pemetrexed in Cancer Patients
This study has been completed.
Sponsor:
Tracon Pharmaceuticals Inc.
Information provided by:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00692159
First received: June 4, 2008
Last updated: September 8, 2010
Last verified: September 2010
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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
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
| 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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013