Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01968915
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: LCL161 Drug: Paclitaxel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968915


Locations
Layout table for location information
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01968915     History of Changes
Other Study ID Numbers: CLCL161A1102
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LCL161, Paclitaxel, Japanese patient, Neoplasms

Additional relevant MeSH terms:
Layout table for MeSH terms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action