Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Dose finding study to estimate the maximum tolerated dose(s) (MTD) and/or recommended dose(s) for safety expansion (RDE) followed by an expansion phase to further assess the safety and preliminary activity of the combination. BYL719 tablets will be administered orally on a daily schedule (q.d.). a b.i.d. regimen may be explored. AUY922 will be administered by IV infusion once per week.

AUY922 is a non-geldanamycin inhibitor of the heat shock protein 90 (HSP90).

AUY922

BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.

BYL719

Novartis Pharmaceuticals

The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.

The study includes a dose escalation part followed by a safety expansion phase.

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

A Phase IB, Multicenter, Open-label Dose Escalation Study of the PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer Carrying a Molecular Alteration of PIK3CA or an Amplification of HER2

To determine the maximum tolerated dose (MTD) and/or Recommended dose for expansion (RDE) and schedule of BYL719 and AUY922 when used as a combination in patients with advanced or metastatic gastric cancer carrying a molecular alteration of PIK3CA and/or an amplification of HER2. 1 cycle = 28days

To characterize the safety and tolerability of BYL719 and AUY922 in combination.

To assess the preliminary anti-tumor activity of BYL719/AUY922 combination from Treatment start to disease progression

To determine the single dose PK of BYL719 single dose, and multiple doses PK of BYL719.

To assess the preliminary anti-tumor activity of BYL719/AUY922 combination.

To determine the single dose and multiple dose pharmacokinetics of AUY922

To determine pharmacokinetics of BJP762 after single dose and multiple dose of AUY922

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer	NCT01613950	Stomach Neoplas...	AUY922 BYL719	18 Years -	Novartis
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer	NCT01613950	Stomach Neoplas...	AUY922 BYL719	18 Years -	Novartis

Spots Global Cancer Trial Database for gastric cancer advanced gastric or metastatic gastric cancer pi3k pik3ca mutation her2 amplification hsp90 inhibitor pi3k inhibitor pik3ca amplification