NCT00881946

Brief Summary

The purpose of this study is to characterize the safety and tolerability of repeat doses of compound GSK2110183 in subjects with hematologic cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2009

Typical duration for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

March 20, 2009

Last Update Submit

April 3, 2012

Conditions

Hematologic Malignancies

Keywords

chronic lymphocytic leukemiaaggressive lymphomanon-Hodgkin's lymphomaHodgkin's lymphomachronic myelogenous leukemiamultiple myelomaacute lymphoblastic leukemiaacute myeloid leukemia

Outcome Measures

Primary Outcomes (12)

  • Physical exam

    Screening, Days -3, 8, At the start of each additional Cycle

  • Electrocardiogram (ECG)

    Days -3, -2, -1, 8, 15, At the start of each additional Cycle

  • Vital signs

    Screening, Days -3, -2, -1, 8, 15, At the start of each additional Cycle

  • Transthoracic Echocardiogram (TTE)/Multiple Gated Acquisition (MUGA) Scans

    Screening, Additionally as needed

  • Clinical Laboratory assessments

    Screening, Days -3, 1, 8, 15, At the start of each additional Cycle

  • ECOG Peformance Status

    Screening, Days -3, 8, At the start of each additional Cycle

  • PK - Maximum observed plasma concentraion (Cmax)

    Days -3, -2, -1, 8, 15

  • PK - time to Cmax [tmax] (Maximum observed plasma concentration)

    Days -3, -2, -1, 8, 15

  • PK - Area under the plasma concentration-time curve (AUC(0-t))

    Days -3, -2, -1, 8, 15

  • PK - Apparent terminal phase elimination rate constant

    Days -3, -2, -1, 8, 15

  • PK - Apparent terminal phase half-life (t1/2)

    Days -3, -2, -1, 8, 15

  • PK - oral clearance (CL/F)

    Days -3, -2, -1, 8, 15

Secondary Outcomes (1)

  • Metabolite Profiling

    Days -3, 8

Study Arms (1)

GSK2119183

EXPERIMENTAL
Drug: GSK21110183

Interventions

GSK21110183DRUG

Starting Dose = 25mg once daily with dose escalation until unacceptable toxicity develops

GSK2119183

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent is provided.
  • Male or female who is at least 18 years of age or older.
  • Histologically- or cytologically-confirmed diagnosis of a hematologic malignancy - that has relapsed or is refractory after standard therapy, AND that is not associated with human immunodeficiency virus (HIV) infection or solid organ transplant, including:
  • chronic lymphocytic leukemia (CLL),
  • chronic myelogenous leukemia (CML),
  • multiple myeloma (MM),
  • non-Hodgkin's lymphoma (NHL),
  • Hodgkin's lymphoma, or
  • Other hematologic malignancy excluding:
  • acute leukemia of any type
  • CML blast crisis
  • myelodysplastic syndrome (MDS)
  • myelofibrosis
  • Performance Status score of 0 and 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
  • Able to swallow and retain oral medication.
  • +6 more criteria

You may not qualify if:

  • Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of study drug.
  • Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug.
  • Current use of a prohibited medication or requires any of these medications during treatment with study drug.
  • Current use of anticoagulants at therapeutic levels within seven days prior to the first dose of study drug, including warfarin, low molecular weight heparin and direct thrombin inhibitors. Low dose (prophylactic) anticoagulants are permitted provided that subject's PT and PTT meet entry criteria.
  • Current use of any anti-platelet agent (e.g. dipyridamole, clopidogrel) other than aspirin (81 mg daily).
  • Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption (e.g. malabsorption syndrome) or predispose subject to gastrointestinal ulceration.
  • Any major surgery within the last four weeks.
  • Unresolved toxicity (except alopecia) Grade 2 from previous anti-cancer therapy unless agreed to by a Medical Monitor and the Investigator
  • Previously diagnosed diabetes mellitus (Type 1 or 2).
  • Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids.
  • Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or with obtaining informed consent.
  • Symptomatic or untreated central nervous system (CNS) involvement by the hematologic malignancy (including primary CNS lymphoma).
  • Evidence of severe or uncontrolled systemic diseases
  • Known infection with HIV, HBV or HCV.
  • QTc interval ≥ 470 msecs.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Spencer A, Yoon SS, Harrison SJ, Morris SR, Smith DA, Brigandi RA, Gauvin J, Kumar R, Opalinska JB, Chen C. The novel AKT inhibitor afuresertib shows favorable safety, pharmacokinetics, and clinical activity in multiple myeloma. Blood. 2014 Oct 2;124(14):2190-5. doi: 10.1182/blood-2014-03-559963. Epub 2014 Jul 29.

    PMID: 25075128DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinHodgkin DiseaseLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMultiple MyelomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphomaLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • S. Jamie Freedman, MD, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2009

First Posted

April 15, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

AU(2)CA(1)KR(1)