NCT00646139

Brief Summary

RATIONALE: KX2-391 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 KX2-391 in treating patients with advanced solid tumors or lymphoma that did not respond to treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

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

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 2, 2011

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

March 27, 2008

Last Update Submit

March 1, 2011

Conditions

LymphomaLymphoproliferative DisorderSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrecurrent adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomasplenic marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III mycosis fungoides/Sezary syndromestage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV mycosis fungoides/Sezary syndromestage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Hodgkin lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomapost-transplant lymphoproliferative disordercutaneous B-cell non-Hodgkin lymphomaWaldenstrom macroglobulinemiasmall intestine lymphoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

Secondary Outcomes (3)

  • Safety

  • Pharmacokinetics

  • Biological effects

Interventions

Src kinase inhibitor KX2-391DRUG
immunoenzyme techniqueOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Confirmed diagnosis of advanced solid tumor or lymphoma * Metastatic or unresectable disease * Standard curative or palliative measures do not exist or are no longer effective * Patients with treated brain or ocular metastases are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 14 weeks * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Serum bilirubin ≤ 2.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Serum creatinine ≤ 1.5 times ULN or creatinine clearance \> 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception for 1 month prior to, during, and for 6 months after completion of study treatment * No inflammatory bowel disease, malabsorption syndrome, or other medical condition that may interfere with oral drug absorption * No signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions including, but not limited to, active infections that, in the opinion of the investigator, precludes protocol participation or compliance * No history of any of the following within the past 6 months: * Angina pectoris * Coronary artery disease * Hypertension * Cerebral vascular accident * Transient ischemic attack uncontrolled by medical therapy * No history of confirmed cardiac conduction abnormalities or arrhythmias * No known history of hepatitis B or C, or HIV infection * No known history of coagulation disorders or hemolytic conditions (e.g., sickle cell anemia) PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * No prior major surgery to the upper gastrointestinal tract * More than 2 weeks since prior investigational agents or systemic anticancer agents (28 days for agents with unknown elimination half-lives or known elimination half-lives \> 50 hours) * More than 4 weeks since prior radiotherapy to the sternum, pelvis, scapulae, vertebrae, or skull and recovered * More than 4 weeks since prior major surgery * More than 1 week since prior palliative low-dose radiotherapy to the limbs and recovered * More than 2 weeks since prior and no concurrent hormones (e.g., estrogen contraceptives, hormone replacement, anti-estrogen, or progesterone) or antiplatelet agents * More than 2 weeks since prior and no concurrent anticoagulants (e.g., coumadin) except prophylactic doses of anticoagulants for indwelling venous catheters * More than 2 weeks or 5 half-lives since prior and no concurrent cytochrome P450 modulators (e.g., strong inducers or inhibitors)

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

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

LymphomaLymphoproliferative DisordersPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellIntraocular LymphomaWaldenstrom Macroglobulinemia

Interventions

tirbanibulinImmunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEye NeoplasmsNeoplasms by SiteNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

ImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Alex A. Adjei, MD, PhD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2008

First Posted

March 28, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2008

Study Completion

March 1, 2009

Last Updated

March 2, 2011

Record last verified: 2011-03

Locations

US(1)