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Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Perifosine
Placebo
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
  • For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
  • No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
  • Patients must have at least one measurable lesion by RECIST criteria

Exclusion Criteria:

  • Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Sites / Locations

  • Yale University School of Medicine
  • TN Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Perifosine + Capecitabine

Placebo + Capecitabine

Arm Description

Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days

Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression-free Survival

Full Information

First Posted
March 30, 2010
Last Updated
June 25, 2013
Sponsor
AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT01097018
Brief Title
Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
Acronym
X-PECT
Official Title
A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perifosine + Capecitabine
Arm Type
Active Comparator
Arm Description
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Arm Title
Placebo + Capecitabine
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m2 BID/ Days 1-14
Intervention Type
Drug
Intervention Name(s)
Perifosine
Intervention Description
50 mg daily x 21 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 pill daily x 21 days
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies. For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity. No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine Patients must have at least one measurable lesion by RECIST criteria Exclusion Criteria: Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Bendell, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
44601
Country
United States
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
City
Armonk
State/Province
New York
ZIP/Postal Code
10504
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
New York City
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58504
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
TN Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC). https://meetinglibrary.asco.org/content/98646-114 Abstract Number:LBA3501
Results Reference
result

Learn more about this trial

Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

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