NCT00462358

Brief Summary

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520. This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Typical duration for phase_1

Geographic Reach
1 country

2 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

April 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

3.6 years

First QC Date

April 18, 2007

Last Update Submit

September 24, 2020

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

    Part 1

  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Part 1 and Part 2

Secondary Outcomes (2)

  • Characterize the pharmacokinetics of the study drug.

    Part 1 and Part 2

  • Assess the efficacy of the study drug in terms of tumor response.

    Part 1 and Part 2

Study Arms (2)

ARRY-520

EXPERIMENTAL
Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous

ARRY-520 + G-CSF support

EXPERIMENTAL
Drug: ARRY-520, KSP(Eg5) inhibitor; intravenousDrug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Interventions

ARRY-520, KSP(Eg5) inhibitor; intravenousDRUG

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

ARRY-520ARRY-520 + G-CSF support
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDRUG

Part 1: standard of care; Part 2: standard of care.

ARRY-520 + G-CSF support

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological evidence of malignancy.
  • Advanced solid tumors that have recurred or progressed following standard therapy(ies).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Adequate hematology counts and serum chemistry values.
  • Additional criteria exist.

You may not qualify if:

  • Major surgery within 28 days prior to the first dose of study drug.
  • Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to \<5% of the bone marrow).
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
  • Additional criteria exist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Wayne State University, Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Interventions

filanesibFilgrastimGranulocyte Colony-Stimulating FactorInjections, Subcutaneous

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    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

April 18, 2007

First Posted

April 19, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

US(2)