Status:
COMPLETED
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors With an Alteration of the PIK3CA Gene
Estrogen Receptor Positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 des...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 5 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2020
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT01219699
Start Date
October 5 2010
End Date
April 16 2020
Last Update
September 22 2020
Active Locations (11)
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1
UCSF Medical Center
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)
Nashville, Tennessee, United States, 37203
4
Vanderbilt Univeristy SC
Nashville, Tennessee, United States, 37232