Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: LCL161; Drug: Paclitaxel

• Registration Number: NCT01968915
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Study Start: 2013-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCL161	LCL161	Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1.
LCL161	Paclitaxel	Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1.

Primary Outcome Measures

Name	Time	Method
Adverse events of oral LCL161	From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)	Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel
Frequency of dose limiting toxicities as a function of LCL161 during first cycle	First cycle (21 days)

Secondary Outcome Measures

Name	Time	Method
LCL161 plasma concentration and derived pharmacokinetic parameters	From first cycle and up to 3 cycle (each cycle is 21-day period)
Paclitaxel plasma concentration and derived pharmacokinetic parameters	From first cycle of combination and up to 2 cycle (each cycle is 21-day period)
Adverse events of oral LCL161	From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)	Type and frequency of adverse events of oral LCL161
Tumor response according to RECIST 1.1	Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kobe-city, Hyogo, Japan