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

A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: LCL161; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 466-8560
      • Novartis Investigative Site
  • Hyogo
    • Kobe-city, Hyogo, Japan, 650-0017
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
2. ECOG performance status 0-1.
3. Patients must have recovered from all toxicities related to their previous treatment.

Exclusion criteria:

1. Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade >1.
2. History of or current interstitial lung disease or autoimmune disease.
3. History of or current impaired cardiac function or clinically significant cardiac diseases.
4. Women of child-bearing potential, unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: LCL161; Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.; Drug: Paclitaxel; Patients will receive weekly paclitaxel as intravenous infusion over 1 hour in combination with LCL161, from cycle 2 in dose escalation part or from the first cycle in dose expansion part, and will continue it until unacceptable toxicity, disease progression and/or withdrawal of consent.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of oral LCL161	Type and frequency of 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)
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)
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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLCL161A1102 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: LCL161, Paclitaxel, Japanese patient, Neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CLCL161A1102