Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)
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ClinicalTrials.gov Identifier: NCT01097018 |
Recruitment Status :
Completed
First Posted : April 1, 2010
Last Update Posted : July 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: Capecitabine Drug: Perifosine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 468 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | April 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Perifosine + Capecitabine
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
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Drug: Capecitabine
1000 mg/m2 BID/ Days 1-14 Drug: Perifosine 50 mg daily x 21 days |
Placebo Comparator: Placebo + Capecitabine
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
|
Drug: Capecitabine
1000 mg/m2 BID/ Days 1-14 Drug: Placebo 1 pill daily x 21 days |
- Overall Survival [ Time Frame: Monthly ]
- Progression-free Survival [ Time Frame: Every 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097018

Principal Investigator: | Johanna Bendell, MD | SCRI Development Innovations, LLC |
Responsible Party: | AEterna Zentaris |
ClinicalTrials.gov Identifier: | NCT01097018 |
Other Study ID Numbers: |
Protocol 343 |
First Posted: | April 1, 2010 Key Record Dates |
Last Update Posted: | July 2, 2013 |
Last Verified: | June 2013 |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |