NCT00504790

Brief Summary

This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with cancers that do not respond to standard therapy. This study will be conducted in two stages; a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

June 25, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2012

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2012

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

July 18, 2007

Last Update Submit

July 10, 2018

Conditions

Cancer

Keywords

GSK923295,First Time in Human,pharmacodynamicscancer,maximally tolerated dose, pharmacokinetics,Refractory CancerCENPE,Phase I,

Outcome Measures

Primary Outcomes (4)

  • Safety: - physical exam

    at screen & Day(D) 1 of each cycle and follow-up(F/U)

  • - vital signs and lab tests

    at screen & D1, 8, 15, & 22 for each cycle & F/U

  • - ECGs

    at screen and D1, 8 & 15 for each cycle & F/U

  • continuous monitoring of adverse events

    each visit

Secondary Outcomes (2)

  • Plasma samples of GSK923295 taken at:

    - Day 1 & 15 (Cycle 1) for Stage 1

  • Plasma samples of GSK923295 taken at:

    - Day 1 of each cycle for Stage 2

Study Arms (1)

GSK923295

EXPERIMENTAL

anti-mitotic compound under study

Drug: GSK923295

Interventions

GSK923295DRUG

anti-mitotic compound

GSK923295

Eligibility Criteria

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

You may qualify if:

  • Signed, written informed consent provided.
  • a) Stage 1 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to accepted standard therapies, or for which there is no standard therapy.
  • b) Stage 2 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia that is not responsive to accepted standard therapies, or for which there is no standard therapy.
  • Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
  • years old or older.
  • Male or female
  • A female is eligible to enroll in the study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:
  • Has had a hysterectomy, or
  • Has had a bilateral oophorectomy (ovariectomy), or
  • Has had a bilateral tubal ligation, or
  • Is post-menopausal (demonstrate total cessation of menses for greater than or equal to one year).
  • Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following from at least two weeks prior to study enrolment until completion of the Post Study procedures:
  • An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile and is the sole sexual partner for that woman.
  • +7 more criteria

You may not qualify if:

  • Any major surgery OR prior anti-cancer therapy including but not limited to chemotherapy, radiotherapy, immunotherapy, biological therapy, or investigational therapy within the past 28 days (42 days for prior nitrosureas or mitomycin C).
  • Prior allogeneic or autologous bone marrow transplant.
  • Greater than 30% bone marrow irradiated.
  • Unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy (except alopecia).
  • History of hemolytic anemia (either congenital or acquired) OR current laboratory evidence of hemolysis (Grade 1CTCAE or greater) that includes at least one of the following:
  • Decrease in serum haptoglobin (outside normal institutional laboratory values)
  • Increase in indirect bilirubin (outside normal institutional laboratory values)
  • Peripheral blood smear consistent with hemolysis (presence of schistocytes)
  • Pre-existing peripheral neuropathy or other neurological toxicity ≥ Grade 2.
  • Female subjects who are pregnant or lactating.
  • Any serious or unstable pre-existing medical, psychiatric, active infection or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent.
  • Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
  • QTc prolongation defined as a QTc interval greater than or equal to 450 msecs.
  • Other significant ECG abnormalities including 2nd or 3rd degree AV block or bradycardia (ventricular rate less than 50 beats/min).
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Duarte, California, 91010, United States

Location

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53792-5666, United States

Location

Related Publications (3)

  • Chung V, Fleming RA, Johnson BM, Gauvin J, Cyr TL, Lager JJ, Lu E, Alberti DB, Williams B, Weber BL, Synold T, Holen KD. A phase 1 and first time in human study of the centromere associated protein E (CENP-E) inhibitor GSK923295A in patients with advanced solid rumors. American Association of Clinical Research Annual Meeting 2008, Oral Presentation, Abstract LB 246

    RESULT

  • Fleming RA, Holen KD, Cyr TL, Johnson BM, Gauvin JL, Lager JJ, Williams B, Alberti DB, Weber BL, Grilley-Olson JE, Chung V. A phase I dose escalation and pharmacokinetic study of the novel mitotic checkpoint inhibitor GSK923295A in patients with solid tumors. (Poster). EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Meeting, Geneva, Switzerland, 2008

    RESULT

  • Holen KD, Heath E, Shelman WS, Kirby LC, Johnson BM, Botbyl JD, Grilley-Olson JE, Lampkin TA, Chung V. Phase I, first-in-human study of the centromere-associated protein e (CENP-E) inhibitor GSK923295 in patients with advanced solid tumors (Study CPE107602). American Society of Clinical Oncology 2010, Oral Presentation, Abstract 3012

    RESULT

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

GSK923295

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

June 25, 2007

Primary Completion

May 7, 2012

Study Completion

May 8, 2012

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations

US(3)