Study of XL999 in Patients With Metastatic Colorectal Cancer | NCT00277303

Studies
Study of XL999 in Patients With Metastatic Colorectal Cancer

NCT00277303

Sponsor

Symphony Evolution, Inc.

Status

Terminated

Last Update Posted

Feb 22, 2010Estimated

Enrollment

17Actual

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

XL999

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

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to cardiac toxicities in the subjects

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Aug 2006Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jan 12, 2006

First Submission Date that Met QC Criteria

Jan 12, 2006

First Posted Date

Jan 16, 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

Feb 18, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XL999	Drug	XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate		Inclusion until disease progression
Safety and tolerability		Inclusion until 30 days post last treatment

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival		Inclusion until disease progression
Duration of response		Inclusion until disease progression
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females with histologically confirmed metastatic colorectal cancer
Measurable disease according to Response Criteria for Solid Tumors (RECIST)
At least 1 prior therapeutic regimen (chemotherapy or biologic)
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Adequate organ and marrow function
No other malignancies within 5 years
Signed informed consent

Exclusion Criteria:

Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
Treatment with systemic anticancer therapy within 30 days of XL999 treatment
Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
Uncontrolled and/or intercurrent illness
Pregnant or breastfeeding females
Known HIV

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lynne Bui, MD	Exelixis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Cancer Care, Inc.		Greenbrae	California	94904	United States
Integrated Community Oncology Network; Division of Clinical Research

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided