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

Plain-language summary

This study evaluates the drug BYL719 (Alpelisib) in adults with advanced solid tumors whose tumors have a PIK3CA gene alteration (mutation or amplification) and no remaining standard treatment. It included patients over 18 with confirmed PIK3CA status. It was a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Novartis Pharmaceuticals

Intervention

BYL719, Fulvestrant

Start date

10/5/2010

Estimated completion

4/16/2020

Countries

United States, Germany, Netherlands, Spain, United Kingdom

Related genes

Locations

• San Francisco, United States
• Boston, United States
• Nashville, United States
• Nashville, United States
• Houston, United States
• Essen, Germany
• Würzburg, Germany
• Amsterdam, Netherlands
• Barcelona, Spain
• L'Hospitalet de Llobregat, Spain
• Oxford, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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 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 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, 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