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Completed

NCT Number: NCT01968915

Safety and Tolerability 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

LCL161

Drug

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

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.

Primary outcomes

  1. Frequency of dose limiting toxicities as a function of LCL161 during first cycle

    Time frame: First cycle (21 days)

  2. Adverse events of oral LCL161

    Time frame: 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

Secondary outcomes

  1. Adverse events of oral LCL161

    Time frame: 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

  2. LCL161 plasma concentration and derived pharmacokinetic parameters

    Time frame: From first cycle and up to 3 cycle (each cycle is 21-day period)

  3. Paclitaxel plasma concentration and derived pharmacokinetic parameters

    Time frame: From first cycle of combination and up to 2 cycle (each cycle is 21-day period)

  4. Tumor response according to RECIST 1.1

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2013
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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