Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer
Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib
Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine
During the dose expansion part of study, all patients must have at least one measurable lesion as defined by RECIST criteria.
Patients must have at least one prior trastuzumab-containing regimen
Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
You may not be if
Patients with Central Nervous System (CNS) metastasis which are: symptomatic or require treatment for symptom control and/or growing
Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3) treatment
Impaired cardiac function
Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C).
Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention.
Patients who do not have an archival tumor sample (or sections of it) available or readily obtainable.
Clareo Health | Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
