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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