Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-27 @ 11:22 AM
Study NCT ID:
NCT01711268
Status:
UNKNOWN
Last Update Posted:
2014-05-15
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunitinib Drug Levels and Outcomes in Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure (time on sunitinib treatment)', 'timeFrame': 'Sunitinib duration (median)', 'description': 'This duration extends from the date the patient starts sunitinib until the date sunitinib is abandoned. The group with sunitinib concentration below the population median are expected to have a median Time to Treatment Failure (TTF) of approximately 8 months, compared with 14 months in those with sunitinib concentration above the population median.'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'Every 6 weeks', 'description': 'Pre-specified toxicities (BP, fatigue, diarrhoea, stomatitis, hand-foot syndrome) will be graded every 6 weeks'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Measured from the date of starting sunitinib treatment to the date of death from any cause'}, {'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'Progression as determined by the clinician according to RECIST 1.1 definitions'}, {'measure': 'Time to second line therapy', 'timeFrame': '2 years', 'description': 'Date of starting sunitinib treatment to the date further systemic therapy is started'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sunitinib', 'Renal Cell Carcinoma', 'Therapeutic Drug Monitoring', 'Pharmacokinetic', 'Treatment toxicity'], 'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is 50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib vary approximately 10-fold between patients.\n\nThis study will measure blood levels of sunitinib and its metabolite, and correlate these with side-effects and the response to the treatment. The study aims to establish whether blood levels change with time, and see how useful blood levels are for monitoring patients treated with sunitinib.', 'detailedDescription': 'Rationale: Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used for first-line systemic therapy in metastatic renal cell carcinoma. It is metabolised to a pharmacologically active metabolite, SU012662, which is of equal potency to the parent compound. At a standard 50mg daily dose, variability in plasma levels between patients is approximately ten-fold. In clinical trials, over 30% of patients require a dose reduction due to toxicity. However, some patients can tolerate up to 100mg without excessive toxicity. It is unknown if sunitinib clearance changes with time. Pre-clinical experiments observed tyrosine kinase inhibition at a plasma concentration of 50-100ng/ml.\n\nDesign: This is a prospective non-randomized, Phase II clinical study. Decision to treat patients with single-agent sunitinib is pre-determined by treating specialists before entering this study. Toxicity and trough sunitinib/metabolite levels will be measured every six weeks during treatment.\n\nAim: This study will prospectively examine the relationship between steady-state trough levels of sunitinib/metabolites and the time on treatment, in addition to changes in trough levels over time. Trough levels will also be correlated with other measures of efficacy and treatment-related toxicity. Furthermore, we aim to confirm that the putative target of 50ng/ml correlates with toxicity and time on sunitinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults being treated with sunitinib monotherapy for metastatic renal cell carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic renal cell cancer treated with single agent sunitinib\n* No known primary liver disease and no other severe or uncontrolled concurrent medical conditions\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to sign informed consent\n* Patients unable to give blood\n* Patients who are pregnant, nursing or not using an effective contraception method\n* Patients who had bone-marrow-transplantation prior to sunitinib treatment'}, 'identificationModule': {'nctId': 'NCT01711268', 'acronym': 'CRESTO', 'briefTitle': 'Sunitinib Drug Levels and Outcomes in Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': 'Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes', 'orgStudyIdInfo': {'id': 'HGWH008'}}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Howard Gurney, MBBS (Hon), FRACP', 'role': 'CONTACT', 'email': 'howard.gurney@sydney.edu.au', 'phone': '+61298455200'}, {'name': 'Howard Gurney, MBBS (Hon), FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Crown Princess Mary Cancer Centre, Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}], 'centralContacts': [{'name': 'Howard Gurney, MBBS, FRACP', 'role': 'CONTACT', 'email': 'howard.gurney@sydney.edu.au', 'phone': '+61298455200'}], 'overallOfficials': [{'name': 'Howard Gurney, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Crown Princess Mary Cancer Centre, Westmead'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Sydney Local Health District', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Howard Gurney', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}