Trial · NCT01613950
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
NCT01613950, Phase 1, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer. Trials, record NCT01613950. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01613950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
- NCT number
- NCT01613950
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
- Interventions
- AUY922, BYL719
- First posted
- 2012-06-07
- Last updated
- 2020-12-09
- Other registries' IDs
- eudract:2011-005978-40
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01613950
GET https://conductscience.org/api/trials/v1/NCT01613950/registered