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This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist.
The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGH447 | Experimental | LGH447, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGH447 | Drug | LGH447, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of dose limiting toxicities | Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events as a measure of safety and tolerability of LGH447 | Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms | 28 days and till the end of the study, an average of 84 days |
| Pharmacokinetics profile of LGH447 and its metabolites if appropriate |
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Inclusion Criteria:
-Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.
Exclusion Criteria:
-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33638035 | Derived | Iida S, Sunami K, Minami H, Hatake K, Sekiguchi R, Natsume K, Ishikawa N, Rinne M, Taniwaki M. A phase I, dose-escalation study of oral PIM447 in Japanese patients with relapsed and/or refractory multiple myeloma. Int J Hematol. 2021 Jun;113(6):797-806. doi: 10.1007/s12185-021-03096-9. Epub 2021 Feb 27. |
| Label | URL |
|---|---|
| Results for CLGH447X1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000719080 | LGH-447 |
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PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days |
| Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1 |
| Overall Response Rate | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | Every 28 days till the end of the study, an average of 84 days |
| Disease control rate | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | Every 28 days till the end of the study, an average of 84 days |
| Clinical benefit rate | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | Every 28 days till the end of the study, an average of 84 days |
| Duration of Response | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | 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 |
| Progression Free Survival | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | 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 |
| Time to response | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. | Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response |
| Kobe |
| Hyōgo |
| 650-0017 |
| Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 701-1192 | Japan |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |