A phase I/II open-label, dose escalation study to investigate thesafety, pharmacokinetics, pharmacodynamics and clinicalactivity of GSK525762 in subjects with relapsed, refractoryhematologic malignancies

GlaxoSmithKline Research and Development Limited0 sites180 target enrollmentJuly 24, 2013

ConditionsPatients with relapsed and/or refractory haematological malignancies (lymphoma, leukemia, or multiple myeloma)MedDRA version: 18.0Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with relapsed and/or refractory haematological malignancies (lymphoma, leukemia, or multiple myeloma)
Sponsor: GlaxoSmithKline Research and Development Limited
Enrollment: 180
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 24, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research and Development Limited

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent provided.
•2\. Males and females 18 years old or older.
•3\. In Part 1, subjects must have relapsed and/or refractory hematologic malignancies (leukemias, myeloproliferative neoplasms, lymphomas, and myelomas) for which no standard therapies are available or anticipated to result in remission.
•In Part 2, subjects must have Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), or non\-Hodgkin’s Lymphoma (NHL).
•Subjects with AML (Part 1 and Part 2\), are eligible if they:
•\- have relapsed and/or refractory disease, OR
•\- are \=65 years of age and not candidates for or have refused standard chemotherapy.
•In Part 2, the NHL cohort will separately enrol subjects with double\- and triple hit lymphoma, so that a minimum of 10 subjects with this subset of disease will be enrolled. To be eligible for this sub\-cohort, tumor sample from the subject must demonstrate rearrangement and/or overexpression of MYC and either BCL2 and/or BCL6 genes. Evaluation of double\- or triple\-hit status may be performed via appropriate local testing, and the determination of double\- or triple\-hit diagnosis will be at the discretion of the investigator and GSK Medical Monitor.
•4\. Subjects with a prior history of stem cell transplant are allowed if
•\- At least months has elapsed from the time of transplant, and

Exclusion Criteria

•1\. Haematological malignancy associated with human immunodeficiency virus (HIV) infection or solid organ transplant or history of known Hepatitis B Antigen or positive Hepatitis C antibody (confirmed by Recombinant ImmunoBlot Assay \[RIBA], if available or alternately confirmed by Hepatitis C Virus \[HCV] RNA).
•2\. History or concurrent malignancy of solid tumours, except for below.
•Exception: Subjects who have been disease\-free for 5 years, or subjects with a history of completely resected non\-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled even if less than 5 years have elapsed since treatment. Consult the GSK Medical Monitor if unsure whether second malignancies meet requirements specified above.
•3\. Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization).
•Note: the following are allowed:
•Hydroxyurea for proliferative disease
•Corticosteroids
•Use of hematopoetic growthfactors is permitted at the discretion of the investigator according to published guidelines (e.g., National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), etc.).
•Note: the following are NOT allowed:
•Investigational anti\-cancer drug within 2 weeks (or 5 half\-lives of the drug, whichever is longer) prior to the first dose of GSK525762