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1

NEAREST SITE: 1478 miles
Mary Crowley Cancer Research
Dallas,TX

VISITS: 1 to 4 visits monthly, ongoing

PHASE: I

NCT ID: NCT03829436

TPST-1120 Alone or With a Systemic Therapy in Advanced Triple Negative Breast Cancer

A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of TPST-1120 when it is used alone or with another anti-cancer drug.
Who is this for?
Women and men with triple negative advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once a month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV, once a week</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120 is an investigational drug that targets a protein called PPARα. </li> <li class="seamTextUnorderedListItem">The other drugs it may be given with are nivolumab (Opdivo®), docetaxel (Taxotere®), and cetuximab (Erbitux®). </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a PD-1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxotere is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Erbitux is a targeted therapy that blocks EGFR. It is approved to treat head, neck and colorectal cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03829436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/reading-room/asco/breast-cancer/79947' target='_blank'>Medpage Today: Cetuximab in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.esmo.org/Oncology-News/Promising-Response-Rates-in-Patients-with-Metastatic-TNBC-Treated-with-Nivolumab-After-Induction-Treatment' target='_blank'>ESMO 2017: Promising Response Rates in Patients with Metastatic TNBC Treated with Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Cancer Research UK: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/79/13_Supplement/3606' target='_blank'>Cancer Research: TPST-1120 suppresses tumor growth and stimulates anti-tumor immunity</a> </li></ul>
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