Trial · NCT02160951
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
NCT02160951, Phase 1, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies. Trials, record NCT02160951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02160951
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
- NCT number
- NCT02160951
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Multiple Myeloma
- Interventions
- LGH447
- First posted
- 2014-06-11
- Last updated
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence rate of dose limiting toxicities | 28 days | Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients |
| Secondary | Number of patients with adverse events as a measure of safety and tolerability of LGH447 | 28 days and till the end of the study, an average of 84 days | Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms |
| Secondary | Pharmacokinetics profile of LGH447 and its metabolites if appropriate | Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1 | PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days |
| Secondary | Overall Response Rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Secondary | Disease control rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Secondary | Clinical benefit rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Secondary | Duration of Response | Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Secondary | Progression Free Survival | Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Secondary | Time to response | Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33638035 | DERIVED |
Source PubMed
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/NCT02160951
GET https://conductscience.org/api/trials/v1/NCT02160951/registered