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

Novartis

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Paclitaxel; Drug: LCL161

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968915

CLCL161A1102

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

LCL161

Experimental group

Description:

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.

Treatment:

Drug: LCL161

Drug: Paclitaxel