LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02649673|
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer Ovarian Cancer||Drug: LCL161 Drug: Topotecan Drug: Pegylated GCSF (PEG-GCSF)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Dose-Escalation Study of LCL161 in Combination With Oral Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC) and Select Gynecologic Malignancies|
|Actual Study Start Date :||March 23, 2016|
|Estimated Primary Completion Date :||July 27, 2020|
|Estimated Study Completion Date :||July 27, 2020|
Experimental: LCL161+topotecan+Pegylated GCSF (PEG-GCSF)
Dose Escalation: Groups of 3-6 patients per dose level (DL) will initiate treatment in escalating doses until the maximum tolerated dose (MTD) is reached. MTD is defined as the highest combination of doses that results in dose-limiting toxicities for 2 of 6 patients per dosing group.
Dose Expansion: 24 additional patients will be treated at the MTD in 2 cohorts (SCLC-12 patients; ovarian cancer-12 patients)
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.
Other Name: Hycamtin®
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.
Other Name: pegfilgrastim
- The incidence of dose-limiting toxicities (DLTs) as a measure of safety and tolerability [ Time Frame: 21 days (one cycle) ]The maximum tolerated dose (MTD) of the LCL161/topotecan combination is defined as the highest dose that results in dose-limiting toxicities (DLTs) for 2 of 6 patients during the first 21 days (1 cycle) of treatment, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
- The incidence of acute and chronic treatment-emergent adverse events to further assess safety of the regimen [ Time Frame: weekly for first 3 weeks then every 3 weeks thereafter, projected 6 months. ]The frequency and severity of AEs for all patients receiving at least one dose of treatment will be analyzed per NCI CTCAE v4.
- Best overall response [ Time Frame: every 6 weeks, projected 6 months ]Preliminary anti-tumor activity associated with combination treatment will be described using the best overall response recorded from start of treatment until disease progression, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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): NCT02649673
|United States, Florida|
|Florida Cancer Specialists-Sarasota|
|Sarasota, Florida, United States, 34232|
|United States, Oklahoma|
|Oklahoma University Health Science Center/Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Tennessee|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Melissa Johnson, MD||SCRI Development Innovations, LLC|