Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

Multiple Myeloma Clinical Trial

Official title:

A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160951
• Other study ID #: CLGH447X1101
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Multiple Myeloma

Intervention

Drug:
• LGH447
LGH447, QD

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Okayama-city	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose limiting toxicities	Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients	28 days
Secondary	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
Secondary	Pharmacokinetics profile of LGH447 and its metabolites if appropriate	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results for CLGH447X1101 can be found on the Novartis Clinical Trial Results Website