Trial · NCT01772797
Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
NCT01772797, Phase 1, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer. Trials, record NCT01772797. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01772797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
- NCT number
- NCT01772797
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Anaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer
- Interventions
- LDK378, AUY922
- First posted
- 2013-01-21
- Last updated
- 2020-12-19
- Other registries' IDs
- eudract:2012-004632-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT01772797
GET https://conductscience.org/api/trials/v1/NCT01772797/registered