A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01219699 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-262


This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Keith Flaherty, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit. Only patients who have confirmed PIK3CA mutation will be allowed for screening. - Availability of a representative formalin fixed paraffin embedded tumor tissue sample. - At least one measurable or non-measurable lesion - Age ≥ 18 years - World Health Organization (WHO) Performance Status ≤ 2 - Good organ (hepatic, kidney, BM) function at screening/baseline visit. Exclusion Criteria: - Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed). - Prior treatment with PI3K inhibitor. - Patient with peripheral neuropathy NCI-CTC Grade ≥ 3. - Patient with diarrhea NCI-CTC Grade ≥ 2. - Patient with acute or chronic pancreatitis - Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug. - Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus. - Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Other protocol-defined inclusion/exclusion criteria may apply
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