AMG 757 20160323
A phase 1 study evaluating the safety, tolerability and pharmacokinetics of AMG 757 in subjects with small cell lung cancer
Phase I, Therapeutisch, Peer Reviewed, Multizentrisch, International
Zweitlinie, Drittlinie, > Drittlinie
>= 18 Jahre
Molekulare Marker:
Inclusion Criteria: Subject has provided informed consent prior to initiation of any study-specific activities/procedures Age greater than or equal to 18 years old at the time of signing the informed consent Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC): Part A, C, D, E and F: RR SCLC who progressed or recurred following platinum-based regimen; Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following no more than 6 cycles of first-line platinum-based chemotherapy with the last dose of chemotherapy greater than or equal to 28 days prior to the study day 1 (first-line consolidation setting) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Subjects with treated brain metastases are eligible provided they meet defined criteria Adequate organ function as defined in protocol Exclusion Criteria: History of other malignancy within the past 2 years prior to first dose of AMG 757 with exceptions Major surgery within 28 days of first dose AMG 757 Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757 Exceptions: Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1 Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757 Subjects who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents. Has evidence of interstitial lung disease or active, non-infectious pneumonitis Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757 Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
Studienaktive Standorte
Rekrutierung läuft
Universitätsklinikum Würzburg
97080 Würzburg
Interdisziplinäres Studienzentrum mit Early Clinical Trial Unit
Herr Dr. Horst-Dieter Hummel
Herr Dr. med. Manik Chatterjee