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).

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

288

Study ID:

NCT02783300

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 17 Locations for this study

See Locations Near You

GSK Investigational Site
Denver Colorado, 80218, United States
GSK Investigational Site
Miami Florida, 33136, United States
GSK Investigational Site
Middletown New Jersey, 07748, United States
GSK Investigational Site
Harrison New York, 10604, United States
GSK Investigational Site
New York New York, 10065, United States
GSK Investigational Site
Nashville Tennessee, 37203, United States
GSK Investigational Site
Dallas Texas, 75230, United States
GSK Investigational Site
San Antonio Texas, 78229, United States
GSK Investigational Site
Edmonton Alberta, T6G 1, Canada
GSK Investigational Site
Ottawa Ontario, K1H 8, Canada
GSK Investigational Site
Toronto Ontario, M5G 1, Canada
GSK Investigational Site
Bordeaux Cedex , 33076, France
GSK Investigational Site
Lyon Cedex 08 , 69373, France
GSK Investigational Site
Villejuif cedex , 94805, France
GSK Investigational Site
Amsterdam , 1066 , Netherlands
GSK Investigational Site
Leiden , 2333 , Netherlands
GSK Investigational Site
Rotterdam , 3015 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

288

Study ID:

NCT02783300

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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