PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
NCT ID: NCT01613950
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2012-12-31
2014-03-31
Brief Summary
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The study includes a dose escalation part followed by a safety expansion phase.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BYL719 + AUY922
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
AUY922 is a non-geldanamycin inhibitor of the heat shock protein 90 (HSP90).
BYL719
BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.
Interventions
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AUY922
AUY922 is a non-geldanamycin inhibitor of the heat shock protein 90 (HSP90).
BYL719
BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.
Eligibility Criteria
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Inclusion Criteria
* Patients must not have a complete gastrectomy;
* gastric tumors carrying PIK3CA mutation or amplification, or HER2-overexpression, or both;
* at least one but no more than three previous lines of treatment for advanced or metastatic disease;
* Patients with PIK3CA mutated or amplified tumors must have failed at least one line but no more than three lines of standard chemotherapy and/or targeted agents;Patients with HER2 amplified tumor must have failed at least one line, but no more than three lines, with or without anti-HER2 therapy. All HER2 positive patients are expected to have received trastuzumab unless contraindications were present or trastuzumab was unavailable;
* Performance Status (PS) ≤ 1 ;
* Adequate bone marrow, liver and other organ functions and laboratory parameters;
* Recovery from all AEs of previous anti-cancer therapies, including surgery and radiotherapy, to baseline or to CTCAE Grade ≤ 1, except for alopecia;Negative serum pregnancy (β hCG) test within 72 hrs before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause.
Exclusion Criteria
* history of prior significant toxicity from another PI3K- or HSP90- inhibitor requiring discontinuation of treatment;
* primary CNS tumor or uncontrolled CNS metastasest;
* Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment;
* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus;Patients with diarrhea CTCAE Grade ≥ 2 ;
* Patients with acute or chronic pancreatitis; History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO;
* Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719;
* Patients receiving chronic slow-release formulation of Proton Pump Inhibitors (PPI), H2-antagonists or other gastric pH elevating agents;
* Treatment with therapeutic doses of coumarin-based anticoagulants (e.g., warfarin sodium, Coumadin®). Low doses of courmarin-based anticoagulants;
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Massachusetts General Hospital Mass General 2
Boston, Massachusetts, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Bellinzona, , Switzerland
Novartis Investigative Site
Taipei, , Taiwan
Countries
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Related Links
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Results for CBYL719X2103 can be found on the Novartis Clinical Trials website
Other Identifiers
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2011-005978-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBYL719X2103
Identifier Type: -
Identifier Source: org_study_id