MedDataX Logo

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

NCT ID: NCT01968915

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LCL161, Paclitaxel, Japanese patient, Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

LCL161

Intervention Type DRUG

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

Paclitaxel

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LCL161

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14605

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLCL161A1102

Identifier Type: -

Identifier Source: org_study_id