Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced… (NCT02802423) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.
44 participantsStarted 2027-01-01
Plain-language summary
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.
Who can participate
Age range20 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Females aged 20 - 70 years old at the time of signing the ICF.
✓. Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
✓. ER =\< 10% by immunohistochemistry (IHC) tumor staining;
✓. PR =\< 10% by IHC tumor staining;
✓. HER2-negative defined as one of the following: 0 or 1+ by IHC, or 2+ by IHC and fluorescence in situ hybridization (FISH)-negative (ratio \< 2.0).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000/μL; platelets count greater than or equal to 100,000/μL; hemoglobin must be greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion).
✓. Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.
Exclusion criteria
✕. Patient with brain metastasis.
✕. Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.
✕. Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
✕. Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.
✕. Known history of human immunodeficiency virus (HIV) infection.
✕. Existing anticancer treatment-related toxicities of Grades greater than or equal to 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
✕. Patients with Grade \> 2 neuropathy.
✕. Patient has an active infection requiring systemic therapy.