Clinical Trial VICCPHI1065
A phase IA, multicenter, open-label dose escalation study of oral BYL719, in adult patients with advanced solid malignancies, whose tumors have an alteration of the PIK3CA gene
- Protocol No. VICCPHI1065
- Open Date: 02/01/2011
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To determine the MTD (or RP2D) of oral BYL719 as single agent in adult patients with advanced solid malignancies whose tumors have a mutation of the PIK3CA gene.
- Disease Sites: Phase I
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: BYL719
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01219699
- Secondary Protocol No: CBYL719X2101
This is a phase IA research study. This means that the study drug patients will be taking has shown promising results in animal testing (good tumor control with limited side effects) but only about 16 patients have yet been treated with BYL719. The goal of a phase IA study is to find the safe dose range based on side effects. If possible, the study will also give us an idea of how well BYL719 might work in treating the patient's disease. This study will also help in understanding what BYL719 does to the patient's body & assess what the patient's body does to clear the drug from their system. For this reason, a number of pharmacokinetic (PK) blood samples will be collected during this study.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant)
• 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
• 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, AKT or mTOR inhibitor and failure to benefit
• 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