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

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Trial Identification

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

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

Study ID: NCT02649673

Conditions

Small Cell Lung Cancer

Ovarian Cancer

Interventions

LCL161

Topotecan

Pegylated GCSF (PEG-GCSF)

Study Description

Brief Summary: This trial will investigate the combination of two anti-cancer agents to treat patients with relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational product that has been shown in clinical trials to work together with other anti-cancer agents. In this trial, investigators will determine the optimal dose of LCL161 and topotecan to administer to patients with relapsed/refractory SCLC and ovarian cancers, and examine the safety profile of the drug combination.

Detailed Description: This is an open-label, multicenter, non-randomized dose-escalation study of oral LCL161 administered in combination with oral topotecan. Topotecan is US FDA approved for treating metastatic ovarian cancer, stage IV-B cervical cancer, and small cell lung cancer (SCLC). LCL161, an investigational product, is an oral small-molecule antagonist of inhibitors of apoptosis proteins (IAPs). Preclinical data suggests that IAP antagonists work in synergy with other anti-cancer agents. This study is designed to evaluate the combination of these two agents in patients with SCLC and ovarian cancers where treatment with topotecan would be appropriate. The study will be conducted in 2 parts. In the dose-escalation part of the study, patients with relapsed/refractory SCLC and gynecologic malignancies will be eligible for enrollment to determine the optimal dose of the drug combination to be administered. Patients can continue treatment until disease progression or unacceptable toxicity. The dose-expansion part of the study is limited to patients with ovarian cancer and relapsed/refractory SCLC (2 cohorts with 12 patients each) to further assess safety and preliminary anti-tumor activity. Up to 52 patients are planned for enrollment at 3 centers in the U.S.