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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02160951

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: LGH447	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LGH447 LGH447, QD	Drug: LGH447 LGH447, QD

Arm

Intervention/Treatment

Experimental: LGH447

LGH447, QD

Drug: LGH447

LGH447, QD

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Nagoya-city	Aichi	Japan	467-8602
2	Novartis Investigative Site	Kobe-city	Hyogo	Japan	650-0017
3	Novartis Investigative Site	Kyoto-city	Kyoto	Japan	602-8566
4	Novartis Investigative Site	Okayama-city	Okayama	Japan	701-1192