|Principal Investigator/ Physician||Carole Norden, MD|
|Contact Email||MCI Clinical Trials|
Protocol Title: Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB).
Inclusion Criteria: Patient must have histologically confirmed HER2+ breast carcinoma; have received previous treatment with taxane, trastuzumab, pertuzumab, and T-DM1; have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy; have measure or non-measurable disease assessable by RECIST 1.1; ECOG status of 0 or 1; life expectancy of at least 6 months; have adequate hepatic function; have creatinine clearance ≥ 50 mL/min; INR and aPTT ≤ 1.5 x ULN unless on medication know to alter INR and aPTT (note: Warfarin is a prohibited con med); LVEF ≥ 50% as assessed by ECHO or MUGA documented within 4 weeks prior to first dose of study medication; no evidence of brain metastases; untreated CNS brain metastases not needing immediate local therapy; previous treated brain metastases.
Exclusion Criteria: Patient has been treated with lapatinib within 12 hours of starting study treatment or neratinib, afatinib, or other investigational HER2/EGFR or HER2 TKI at any time previously; previously been treated with capecitabine for metastatic disease; history of exposure to Doxorubicin or liposomal doxorubicin > 360 mg/m2, Epirubicin > 720 mg/m2, Mitoxantrone > 120 mg/m2, Idarubicin > 90 mg/m2, Other anthracyclines (e.g., liposomal doxorubicin) > the equivalent of 360 mg/m2 of doxorubicin; history of allergic reactions to trastuzumab, capecitabine or ONT-380; has received treatment with any systemic anti-cancer thereapy, non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of study treatment; have any toxicity related to prior cancer therapies that has not resolved to ≤ grade 1; clinically significant cardiac disease; have known myocardial infarction or unstable angina within 6 months prior to study treatment; known carrier of Hepatitis B or C; HIV positive; require therapy with warfarin or other coumarin derivatives; have known dihydropyrimidine dehydrogenase deficiency; have used a strong CYP3A4 inducer or inhibitor within 3 elimination half-lives of the inhibitor or inducer prior to first dose of study treatment; and untreated lesions > 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of SNC metastases <28 days prior to first dose; any lesion thought to require immediate local therapy; known leptomeningeal disease; poorly controlled seizures
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02614794?term=ONT-380-206&rank=1
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