A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma
Condition: Neoplasms
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02783300
Sponsor: GlaxoSmithKline
Phase: Phase 1
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
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.
View trial on ClinicalTrials.gov
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