Trial · NCT01613950
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence rate of Dose Limiting Toxicities. | cycle 1 | 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 |
| Secondary | Frequency of adverse events (AEs) | duration of the study, an expected average of 24 months | To characterize the safety and tolerability of BYL719 and AUY922 in combination. |
| Secondary | Best Overall Response (BOR) as per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 | every 6 weeks | To assess the preliminary anti-tumor activity of BYL719/AUY922 combination from Treatment start to disease progression |
| Secondary | Plasma concentration versus time profiles of BYL719 as single agent an in combination with AUY922. | 2 months | To determine the single dose PK of BYL719 single dose, and multiple doses PK of BYL719. |
| Secondary | Overall response rate (ORR) as per RECIST version 1.1 | an expected average of 12 months | To assess the preliminary anti-tumor activity of BYL719/AUY922 combination. |
| Secondary | Progression free survival (PFS) as per RECIST version 1.1 | every 6 weeks | To assess the preliminary anti-tumor activity of BYL719/AUY922 combination. |
| Secondary | Overall survival (OS) | approximately 1 year | To assess the preliminary anti-tumor activity of BYL719/AUY922 combination. |
| Secondary | Overall survival rate at 6 months (OS6) | 6 months | To assess the preliminary anti-tumor activity of BYL719/AUY922 combination. |
| Secondary | Frequency and severity of serious adverse events (SAEs) | duration of the study, an expected average of 24 months | To characterize the safety and tolerability of BYL719 and AUY922 in combination. |
| Secondary | Plasma concentration versus time profile of AUY922 as single agent and in combination with BYL719 | 2 months | To determine the single dose and multiple dose pharmacokinetics of AUY922 |
| Secondary | Plasma concentration versus time profile of the AUY922 metabolite BJP762 | 2 months | To determine pharmacokinetics of BJP762 after single dose and multiple dose of AUY922 |
| Secondary | Severity of adverse events (AEs) | duration of the study, an expected average of 24 months | To characterize the safety and tolerability of BYL719 and AUY922 in combination. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01613950/registered