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Alkylating Agent

TRC102 for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Alice P Chen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase I: histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist.

Life expectancy of greater than 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up response rate one year

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer treatment drug, TRC102, in combination with temozolomide, for advanced solid tumors and lymphomas.

Eligible Conditions

Ovarian Cancer
Non-Hodgkin's Lymphoma
Solid Tumors
Non-Small Cell Lung Cancer
Colon Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have a type of solid tumor that has not responded to standard treatments or for which there are no other treatment options available.

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You are expected to live for at least 3 more months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response rate one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response rate one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and response rate one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the pharmacokinetic (PK) profile of oral TRC102 when administered in combination with TMZ

To establish the safety, tolerability, and maximum tolerated dose (MTD) of oral TRC102 in combination with oral TMZ in patients with refractory solid tumors.

To explore the response rate of this combination in patients with colon cancer, NSCLC, and granulosa cell ovarian cancer

Secondary outcome measures

Malignant Neoplasms

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

combination treatment with oral TRC102 and oral TMZ for days 1-5 of 28-day cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TRC102

2013

Completed Phase 2

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,646 Previous Clinical Trials

40,930,934 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,708 Patients Enrolled for Ovarian Cancer

Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

16 Previous Clinical Trials

3,575 Total Patients Enrolled

Media Library

Temozolomide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01851369 — Phase 1 & 2

Ovarian Cancer Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT01851369 — Phase 1 & 2

Temozolomide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01851369 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being signed up to participate in this clinical trial?

"Yes, the trial is currently ongoing and looking for eligible patients. The posting date was July 12th, 2013 with the most recent update on July 28th, 2022. A total of 140 individuals are needed for the study which will take place at 2 different hospitals or clinics."

Answered by AI

How many total individuals are participating in this clinical trial?

"The information available on clinicaltrials.gov supports that this study is ongoing and looking for volunteers. The trial was inaugurated on July 12th, 2013 with the most recent update being made on July 28th, 2020. A total of 140 people are needed across 2 different locations."

Answered by AI

Has TRC 102 been explored in other research studies?

"At this moment, there are 2 ongoing studies that involve TRC 102. 0 of those trials have reached Phase 3. A plurality of the research is based in Bethesda, Maryland; however, there are 17 total locations running these experiments."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Development of a Validated Immunofluorescence Assay for Γh2ax as a Pharmacodynamic Marker of Topoisomerase I Inhibitor Activity

Kinders, Robert J., Melinda Hollingshead, Scott Lawrence, Jiuping Ji, Brian Tabb, William M. Bonner, Yves Pommier, et al.. 2010. “Development of a Validated Immunofluorescence Assay for Γh2ax as a Pharmacodynamic Marker of Topoisomerase I Inhibitor Activity”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-09-3076.

Pharmacological ResearchJournal

Triazene Compounds: Mechanism of Action and Related DNA Repair Systems

MARCHESI, F, M TURRIZIANI, G TORTORELLI, G AVVISATI, F TORINO, and L DEVECCHIS. 2007. “Triazene Compounds: Mechanism of Action and Related DNA Repair Systems”. Pharmacological Research. Elsevier BV. doi:10.1016/j.phrs.2007.08.003.

Clinical Cancer ResearchJournal

Combined Treatment with Temozolomide and Methoxyamine: Blocking Apurininc/pyrimidinic Site Repair Coupled with Targeting Topoisomerase Iiα

Yan, Ling, Alina Bulgar, Yanling Miao, Varun Mahajan, Jon R. Donze, Stanton L. Gerson, and Lili Liu. 2007. “Combined Treatment with Temozolomide and Methoxyamine: Blocking Apurininc/pyrimidinic Site Repair Coupled with Targeting Topoisomerase Iiα”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-06-1595.

clinicaltrials.govStudy