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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968915
• Other study ID #: CLCL161A1102
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Nagoya-city	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of dose limiting toxicities as a function of LCL161 during first cycle		First cycle (21 days)
Primary	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	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)
Secondary	LCL161 plasma concentration and derived pharmacokinetic parameters		From first cycle and up to 3 cycle (each cycle is 21-day period)
Secondary	Paclitaxel plasma concentration and derived pharmacokinetic parameters		From first cycle of combination and up to 2 cycle (each cycle is 21-day period)
Secondary	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)

External Links

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