Open-Label Study to Assess the Safety/Tolerability in Pat... | NCT00820560

Studies
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors

NCT00820560

Sponsor

Incyte Corporation

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

41Actual

Phase

Phase 1

Conditions

Solid Tumors and Hematologic Malignancy

Interventions

INCB007839

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

Jan 2018

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

Jan 2005

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 12, 2009Estimated

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

Jan 15, 2018

Last Update Posted Date

Jan 17, 2018Actual

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

To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.

Detailed Description

Not provided

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

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INCB07839 100mg, immediate release (IR) capsules	Experimental		Drug: INCB007839
INCB07839 200 mg IR capsules	Experimental		Drug: INCB007839

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INCB007839	Drug	INCB007839 100 or 200 mg/dose as IR capsules	INCB07839 100mg, immediate release (IR) capsules INCB07839 200 mg IR capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments		Baseline through study completion

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of response rates as measured by RECIST criteria		At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response		Baseline and every visit through study termination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
Evidence of venous thrombosis by flow Doppler examination at Screening
A history of thrombosis or a coagulation disorder
Patients with a contraindication to use of low dose warfarin and/or aspirin.
Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
Brain metastases or spinal cord compression
Impaired renal function
Inadequate bone marrow reserve

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
William V Williams, MD	Incyte Corporation	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Aurora	Colorado		United States