Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01097018
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2010-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
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Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'dispFirstSubmitDate': '2013-06-18', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2010-03-30', 'dispFirstSubmitQcDate': '2013-06-18', 'studyFirstSubmitQcDate': '2010-03-30', 'dispFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Monthly'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Every 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', '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'}]}, 'descriptionModule': {'briefSummary': 'The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.\n* No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine\n* Patients must have at least one measurable lesion by RECIST criteria\n\nExclusion Criteria:\n\n* Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU'}, 'identificationModule': {'nctId': 'NCT01097018', 'acronym': 'X-PECT', 'briefTitle': 'Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AEterna Zentaris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Protocol 343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Perifosine + Capecitabine', 'description': 'Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days', 'interventionNames': ['Drug: Capecitabine', 'Drug: Perifosine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Capecitabine', 'description': 'Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days', 'interventionNames': ['Drug: Capecitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': '1000 mg/m2 BID/ Days 1-14', 'armGroupLabels': ['Perifosine + Capecitabine', 'Placebo + Capecitabine']}, {'name': 'Perifosine', 'type': 'DRUG', 'description': '50 mg daily x 21 days', 'armGroupLabels': ['Perifosine + Capecitabine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 pill daily x 21 days', 'armGroupLabels': ['Placebo + Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, 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