NCT00443976

Brief Summary

RATIONALE: Aurora kinase inhibitor AT9283 (AT9283) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in treating patients with advanced or metastatic solid tumors or non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 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

January 30, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2012

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

March 5, 2007

Last Update Submit

August 3, 2023

Conditions

Non-Hodgkins LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrecurrent adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomanodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomarecurrent adult grade III lymphomatoid granulomatosisadult grade III lymphomatoid granulomatosisWaldenstrom macroglobulinemia

Outcome Measures

Primary Outcomes (4)

  • Maximum tolerated dose of Aurora kinase inhibitor AT9283 (AT9283)

    Doses escalated as described in protocol section 4.3. MTD defined as that dose at which ≥ 2/6 or ≥ 2/3 patients experience DLT (as defined in protocol section 4.4).

    1 year

  • Recommended phase II dose of AT9283

    RPTD defined as one dose lower than MTD.

    1 year

  • Safety, tolerability, toxicity profile, and dose-limiting toxicity of AT9283

    Adverse events graded using NCI CTCAE V3.0

    every 3 weeks

  • Pharmacokinetic profile of AT9283

    PK samples collected on all patients during cycle 1 as described in protocol section 17.2.

    cycle one only

Secondary Outcomes (1)

  • Efficacy of AT9283

    every 6 weeks

Study Arms (1)

AT9283

EXPERIMENTAL
Drug: Aurora kinase inhibitor AT9283

Interventions

Aurora kinase inhibitor AT9283DRUG

The starting dose of AT9283 will be 1.5 mg/m2 given as a 24 hour IV infusion on Days 1 and 8 every three weeks.

AT9283

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of 1 of the following: * Advanced and/or metastatic solid tumor * Advanced or metastatic non-Hodgkin's lymphoma refractory to standard therapy * Clinically or radiologically documented disease * No tumor marker elevation as only evidence of disease * No untreated brain or meningeal metastases * Treated and stable brain metastases allowed provided they are asymptomatic and do not require steroids PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min * Bilirubin normal * ALT and AST ≤ 2 times ULN (≤5 times ULN if liver metastases are present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use two effective methods of contraception * No untreated or uncontrolled hypertension, cardiovascular conditions, or symptomatic cardiac dysfunction * No active or uncontrolled infections * No serious illness or medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior major surgery and recovered * At least 3 weeks since prior palliative radiotherapy and recovered * Low-dose, nonmyelosuppressive radiotherapy may be allowed * At least 3 weeks since prior chemotherapy for solid tumors and recovered * No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease * At least 4 weeks since prior steroids * No limitations on prior therapy for patients with non-Hodgkin's lymphoma * Prior hormonal, immunologic, biologic or signal transduction inhibitor therapy allowed * No other concurrent investigational agents * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

  • Dent SF, Gelmon KA, Chi KN, Jonker DJ, Wainman N, Capier CA, Chen EX, Lyons JF, Seymour L. NCIC CTG IND.181: phase I study of AT9283 given as a weekly 24 hour infusion in advanced malignancies. Invest New Drugs. 2013 Dec;31(6):1522-9. doi: 10.1007/s10637-013-0018-9. Epub 2013 Sep 27.

    PMID: 24072436RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinBurkitt LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Karen A. Gelmon, MD

    British Columbia Cancer Agency

    STUDY CHAIR

  • Susan F. Dent, MD

    Ottawa Regional Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

January 30, 2007

Primary Completion

April 9, 2010

Study Completion

January 6, 2012

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)