Trial · NCT01772797
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence rate of Dose Limiting Toxicities (DLT) | up to day 28 after the patient's first dose | cycle = within the first 28 days of patient's first dose |
| Secondary | Number of patients with adverse events | 30 months | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
| Secondary | Changes in laboratory values | 30 months | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
| Secondary | Assessments of electrocardiograms | 30 months | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
| Secondary | Assessments of dose interruptions, reductions, and dose intensity | 30 months | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: Tmax | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
| Secondary | Overall response rate (ORR) | 30 months | Assess the anti-tumor activity of LDK378 and AUY922 |
| Secondary | Duration of Response (DoR) | 30 months | Assess the anti-tumor activity of LDK378 and AUY922 |
| Secondary | Time to Response (TTR) | 30 months | Assess the anti-tumor activity of LDK378 and AUY922 |
| Secondary | Progression free survival (PFS) | 30 months | Assess the anti-tumor activity of LDK378 and AUY922 per RECIST 1.1 |
| Secondary | Number of patients with serious adverse events | 30 months | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: Cmax | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: AUClast | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: AUCtau | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: Cmin | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
| Secondary | Plasma PK parameter of LDK378 and AUY922: Racc | 30 months | Characterize single and multiple dose PK of LDK378 and AUY922 in patients |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01772797/registered