Evaluation of KX2-391 in Patients With Advanced Malignancies | NCT00658970

Studies
Evaluation of KX2-391 in Patients With Advanced Malignancies

NCT00658970

Sponsor

Athenex, Inc.

Status

Completed

Last Update Posted

Jun 8, 2011Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Solid Tumors
Lymphoma

Interventions

KX2-391

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Apr 10, 2008

First Posted Date

Apr 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.

Detailed Description

The purpose of this first in human study is to determine the safety and pharmacokinetics of KX2-391 in patients with solid tumors and lymphoma, who are refractory to conventional cancer treatments. In addition, pharmacodynamics will be evaluated using biomarkers in peripheral blood mononuclear cells and in tissue biopsy samples.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
KX2-391	Drug	2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops

Measure	Description	Time Frame
Determine maximum tolerated dose of the drug		64 days

Measure	Description	Time Frame
Pharmacokinetics, Pharmacodynamics, Efficacy		64 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Adults over age 18 years of age
Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with treated brain or ocular metastases are also eligible
ECOG performance status of 0-2
Life expectancy of at least 14 weeks
Adequate bone marrow reserve
Adequate liver function as demonstrated by serum bilirubin, alanine aminotransferase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)
Adequate renal function (serum creatinine </= 1.5 x ULN or calculated creatinine clearance > 60 ml/min)
Normal coagulation profile (PT/INR and aPTT within institutional normal limits) for those who give consent to tumor biopsy, within 1 week prior to the procedure.
Negative pregnancy test for females at Screening, preferably done within 1 week before Day 1 of dosing (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
Willing to abstain from sexual activity or practice physical barrier contraception 28 days before Day 1 of dosing and 6 months after the last dose for the patient
Signed written informed consent for tumor biopsy for the additional 10 subjects that will be dosed at the MTD and who have accessible tumors

Exclusion Criteria:

Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer treatment or investigational agents
Receiving or having received investigational agents or systemic anti-cancer agents within 14 days of Day 1 of dosing or 28 days for those agents with unknown elimination half-lives or half-lives of greater than 50 hours
Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or skull, \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Aung Naing, M.D.	M.D. Anderson Cancer Center	Principal Investigator
Roger B Cohen, M.D.	Fox Chase Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fox Chase Cancer Center		Philadelphia	Pennsylvania	19111	United States
MD Anderson Cancer Center

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases