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Brief Title: Dose Escalation Study of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin’s Lymphoma

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

INTRODUCTION

  • Org Study ID: 204653
  • Secondary ID: N/A
  • NCT ID: NCT02783300
  • Sponsor: GlaxoSmithKline

BRIEF 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).

  • Overall Status
    Completed
  • Start Date
    August 30, 2016
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Neoplasms

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: GSK Clinical Trials

Role: Study Director

Affiliation: GlaxoSmithKline

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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