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(Last updated: November 13, 2019)

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NEAREST SITE: 348 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02264678

AZD6738 with Chemotherapy and/or Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. Scientific Title

Purpose
To study the safety, effects, and best dose of AZD6738 when it is used alone or with the chemotherapy drug carboplatin or the PARP inhibitor olaparib (Lynparza®).
Who is this for?
Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Open to all MBC patients</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Open to all MBC patients </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Open to Triple Negative Breast Cancer MBC patients with or without a BRCA mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 biopsies (at baseline, last day of dosing and following progression of disease)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738 is a new type of targeted therapy called an ATR inhibitor. </li> <li class="seamTextUnorderedListItem">It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. </li> <li class="seamTextUnorderedListItem">Carboplatin is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor approved to treat BRCA positive metastatic breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02264678' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: AZD6738</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/olaparib' target='_blank'>NCI Drug Dictionary: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/targeting-cancers-achilles-heel-dna-damage-response-networks-beyond-parp' target='_blank'>OncLive: DNA Damage Response Networks Beyond PARP</a> </li></ul>
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