LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

PHASE1TerminatedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 23, 2016

Primary Completion Date

July 30, 2021

Study Completion Date

July 30, 2021

Conditions
Small Cell Lung CancerOvarian Cancer
Interventions
DRUG

LCL161

DRUG

Topotecan

Topotecan will also be administered orally. Patients in DL 1 will receive topotecan at 1.8 mg/m2 per day for the first 5 days of each 21-day cycle. Patients in DL 2 will receive topotecan at 2.3 mg/m2 per day for the first 5 days of each 21-day cycle. The maximum dose for topotecan will not exceed 2.3 mg/m2 per day in this study.

DRUG

Pegylated GCSF (PEG-GCSF)

Pegylated GCSF (PEG-GCSF) (e.g. pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting.

Trial Locations (3)

34232

Florida Cancer Specialists-Sarasota, Sarasota

37203

Tennessee Oncology PLLC, Nashville

73104

Oklahoma University Health Science Center/Stephenson Cancer Center, Oklahoma City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER