Study of XL820 Given Orally Daily to Subjects With Solid... | NCT00350831

Studies
Study of XL820 Given Orally Daily to Subjects With Solid Tumors

NCT00350831

Sponsor

Exelixis

Status

Completed

Last Update Posted

Aug 18, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Cancer

Interventions

XL820

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

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 7, 2006

First Submission Date that Met QC Criteria

Jul 7, 2006

First Posted Date

Jul 11, 2006Estimated

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

Aug 14, 2008

Last Update Posted Date

Aug 18, 2008Estimated

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

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
XL820	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
Subject is at least 18 years old
Subject has ECOG performance status ≤ 2
Subject has a life expectancy of > 3 months
Subject has adequate organ and marrow function
In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
Subject has given written informed consent
Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
Subject has received an investigational agent within 30 days of the first dose of XL820
Subject has known brain metastases
Subject has known uncontrolled intercurrent illness
Subject is pregnant or lactating
Subject is known to be positive for HIV
Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation

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

Measure	Description	Time Frame
maximum tolerated dose
safety and tolerability

Measure	Description	Time Frame
plasma pharmacokinetics
pharmacodynamic effects
long-term safety and tolerability

Facility	Status	City	State	ZIP	Country	Contacts
The Cancer Institute of New Jersey		New Brunswick	New Jersey	08901	United States
Cancer Therapy and Research Center