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

NCT01968915 | Completed Phase 1

• 1 other identifier: CLCL161A1102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Keywords

LCL161, Paclitaxel, Japanese patient, Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (1)

LCL161

EXPERIMENTAL

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; Drug: Paclitaxel

Interventions

LCL161 DRUG

Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.

LCL161

Paclitaxel DRUG

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.

LCL161

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

LCL161; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 19, 2020

Record last verified: 2016-01

Locations

JP (2)