Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma
NCT02689167
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Men or women over 18 years old
- Patients with local, advanced or inoperable or metastatic (MRCC) renal cell carcinoma who are starting first line treatment with Sunitinib 50mg (4/6 regimen) according to the Marketing Authorisation Indication
- Patients with histologically or cytologically confirmed renal cancer, clear cell variant or with a clear cell component
- Karnofsky performance status ≥ 70%
- Adequate organ function:
- Absolute neutrophil (N) count ≥ 1 500 / µL
- Platelets ≥ 100 000 / µL
- Haemoglobin ≥ 10 g/dL
- Adjusted serum calcium ≤ 2.6 mmol/L
- Creatinine clearance ≥ 30 mL/min (by the MDRD formula)
- Total bilirubin ≤ 1.5 x ULN (upper limit of the normal range)
- AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN OR AST and ALT ≤ 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase
Key
- Renal carcinoma with no clear cell component.
- Previous systemic treatment for the RCC regardless of type (including targeted
therapy, immunotherapy, chemotherapy, hormone or experimental therapy). Previous or
concomitant treatment with a bisphosphonate or denosumab is allowed.
- Patients whose clinical state and comorbidities are not consistent with administration
of Sunitinib at the initial dose of 50mg/day 4 weeks out of 6.
- Grade 3 haemorrhage within 4 weeks before starting treatment with Sunitinib (according
to the NCI-CTCAE toxicity score version 3.0).
- The presence of a past history of cancer in the 3 years before inclusion into the
study
- Major surgery within 4 weeks before sunitinib initiation
- Past history of symptomatic cerebral metastases, spinal cord compression or meningeal
carcinomatosis. Patients with cerebral metastases discovered incidentally on imaging
and who are asymptomatic are not excluded if these metastases have been treated
(radiotherapy and/or surgery) with a period of at least 4 weeks between the end of
treatment and inclusion into the study and no clinical or radiological signs of
relapse, and corticosteroid dose is not exceeding 10mg/day of prednisone or
equivalent. Subjects will be excluded if subjects have signs of grade ≥ 2
treatment-related complications.
- Any of the following features within 6 months of the administration of Sunitinib:
myocardial infarction, severe/unstable angina, coronary artery/peripheral artery
bypass graft, symptomatic congestive heart failure, cerebrovascular accident or
transient ischemic attack.
- Pulmonary embolism or deep vein thrombosis within 3 months of inclusion (unless it's
stable, asymptomatic and treated with a low molecular weight heparin for at least 6
weeks before inclusion).
- Any known acute or chronic disorder (such as severe chronic obstructive pulmonary
disease) which in the opinion of the investigator could impact on the patient's
capacity to receive the study treatment or make interpretation of toxicity or adverse
events difficult.
- Known HIV infection.
- History of chronic active hepatitis including subjects who are carriers of the
hepatitis B (HBV) or hepatitis C (HCV) virus.
- Existence of uncontrolled infection.
- Uncontrolled hypertension defined as a blood pressure of > 150 mmHg systolic or > 100
mmHg diastolic despite optimal anti-hypertensive therapy (blood pressure must be
controlled at inclusion).
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- Besancon, Franche-Comté
Descriptive Information | |||||
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Brief Title ICMJE | Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma | ||||
Official Title ICMJE | Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma | ||||
Brief Summary | Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off " As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: Sunitinib | ||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 248 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 2024 | ||||
Estimated Primary Completion Date | March 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02689167 | ||||
Other Study ID Numbers ICMJE | P/2015/254 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Besancon | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Besancon | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |