Breast Cancer Clinical Trial
An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin’s Lymphoma
Summary
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).
Eligibility Criteria
Inclusion criteria:
Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
Presence of evaluable disease
Adequate organ function (as defined in the protocol)
Reproductive criteria (as defined in the protocol).
Exclusion Criteria:
Malignancy attributed to prior solid organ transplant
Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)
History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
Select cardiac abnormalities (as defined in the protocol)
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
History of optic nerve neuropathy or neuritis.
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There are 17 Locations for this study
Denver Colorado, 80218, United States
Miami Florida, 33136, United States
Middletown New Jersey, 07748, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
San Antonio Texas, 78229, United States
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Bordeaux Cedex , 33076, France
Lyon Cedex 08 , 69373, France
Villejuif cedex , 94805, France
Amsterdam , 1066 , Netherlands
Leiden , 2333 , Netherlands
Rotterdam , 3015 , Netherlands
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