Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer (PIKNIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02506556|
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: BYl719||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Exploratory, Open-label, Single Arm Study of BYL719 Monotherapy, a Selective Phosphatidylinositol 3-kinase (PI3K) Alpha Inhibitor, in Adult Patients With Advanced Breast Cancer Progressing After First Line Therapy.|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
BYL719 350 mg orally daily until progression, undue adverse events or withdrawal of consent.
Treatment: BYL719 350mg orally daily Treatment will be given daily until progression, undue adverse events or withdrawal of consent.
Dose reductions (two levels) are allowed. Each cycle is 28 days
- Objective response rate [ Time Frame: > 6 months ]The percentage of patients who achieve a complete or partial response as defined by RECIST 1.1 criteria.
- Clinical Benefit Rate [ Time Frame: > 6 months ]Defined as Complete or partial responses according to RECIST 1.1 criteria or stable disease for 6 months or greater
- Progression free survival [ Time Frame: > 6 months ]Defined as the time from study entry until documented disease progression
- Safety and tolerability [ Time Frame: > 6 months ]Safety and tolerability will be described using frequency of significant treatment related adverse events (AEs) using CTCAE 4.0 grade ≥3, all Serious Adverse Events and SUSARs. Safety analysis will include all patients who have received at least one dose of the drug and will be evaluated descriptively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506556
|Contact: MedOnc1 Clinical Trials Unit||+61396561111 (ask for CTU)||firstname.lastname@example.org|
|Contact: Terese Masters||+61396561111 ext email@example.com;|
|Peter MacCallum Cancer Centre||Recruiting|
|East Melbourne, Victoria, Australia, 3002|
|Contact: MEDONC1 Team clinical trials unit +61396561111 firstname.lastname@example.org|
|Contact: Terese Masters +61396561111 ext 3642 email@example.com|
|Study Chair:||Sherene Loi, MD,PhD||Peter MacCallum Cancer Centre, East Melbourne, Victoria, AUSTRALIA|