Safety and Efficacy of LCL161 in Patients With Solid Tumors

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: LCL161

Study type: Interventional

Funder types: Industry

Identifiers

NCT01098838

CLCL161A2101

Details and patient eligibility

About

The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Solid tumor
• ECOG performance status 0-2
• Life expectancy greater than or equal to 12 weeks
• Must meet certain blood laboratory values
• Must meet criteria for time since the last dose of prior therapy
• Must provide written informed consent to participate in this study

Exclusion criteria

• Active and/or symptomatic brain tumors or brain metastases.
• Patients with unresolved nausea, vomiting, or diarrhea
• Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease
• Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel)
• Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug
• Patients who are currently receiving treatment with certain medications
• Patients who have received radiation therapy or have undergone major surgery within the last 4 weeks
• Women of child-bearing potential who are pregnant or breast feeding.
• Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
• Patients unwilling or unable to follow the protocol

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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71 participants in 3 patient groups

Weekly dosing of LCL161

Experimental group

Description:

by mouth (oral)

Treatment:

Drug: LCL161

Comparison of LCL161

Experimental group

Description:

tablet versus liquid

Treatment:

Drug: LCL161

Twice daily dosing of LCL161

Experimental group

Description:

by mouth for 4 days followed by a 3-day rest period every week

Treatment:

Drug: LCL161