Trial · NCT01430416
Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
NCT01430416, Phase 1, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients. Trials, record NCT01430416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
- NCT number
- NCT01430416
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 153 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Uveal Melanoma
- Interventions
- AEB071
- First posted
- 2011-09-08
- Last updated
- 2020-12-19
- Other registries' IDs
- eudract:2011-002535-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation | cycle 1 (28 days) | |
| Primary | Number of participants reporting serious adverse events and adverse events - Dose Expansion | Baseline, every 28 days | |
| Secondary | Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1 | Baseline, 12 months | |
| Secondary | Progression free survival and time to progression using RECIST version 1.1 | Baseline, 12 months | |
| Secondary | Number of patients reporting serious adverse events and adverse events | Baseline, 12 months | |
| Secondary | AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA | First 7 months of treatment period | |
| Secondary | Gα genotype in tumor specimens | Baseline, 28 days |
Source ClinicalTrials.gov
Outcomes0
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT01430416
GET https://conductscience.org/api/trials/v1/NCT01430416/registered