Study of TRC102 in Combination With Pemetrexed in Cancer Patients

NCT ID: NCT00692159

Last Updated: 2010-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Dose finding single arm

Group Type EXPERIMENTAL

TRC102 + pemetrexed

Intervention Type DRUG

Oral TRC102 solution + IV pemetrexed

Interventions

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TRC102 + pemetrexed

Oral TRC102 solution + IV pemetrexed

Intervention Type DRUG

Other Intervention Names

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Alimta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tracon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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TRACON Pharmaceuticals Inc.

Principal Investigators

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Bryan Leigh, MD

Role: STUDY_DIRECTOR

Tracon Pharmaceuticals Inc.

Locations

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Scottsdale, Arizona, United States

Site Status

Santa Monica, California, United States

Site Status

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23054206 (View on PubMed)

Related Links

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http://www.traconpharma.com

TRACON Pharmaceuticals Inc. Web Site

Other Identifiers

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102ST101

Identifier Type: -

Identifier Source: org_study_id