Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

NCT02689167

Last updated date
Study Location
CHU Besancon
Besancon, Franche-Comté, 25030, France
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms, Metastatic Renal Cell Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Kidney Neoplasms, Metastatic Renal Cell CancerStudy to Assess Various Sunitinib Schedules in Renal Cell Carcinoma
NCT02689167
  1. Besancon, Franche-Comté
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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:

  • Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
  • Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "
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
  • Kidney Neoplasms
  • Metastatic Renal Cell Cancer
Intervention  ICMJE Drug: Sunitinib
Study Arms  ICMJE
  • Active Comparator: Arm A 4/6
    Sunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "
    Intervention: Drug: Sunitinib
  • Experimental: Arm B 2/3
    Sunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "
    Intervention: Drug: Sunitinib
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
 (submitted: February 18, 2016)
248
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elise Robert[email protected]
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
Plan to Share IPD:No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:antoine thiery-vuillemin, MD PhDCentre Hospitalier Universitaire de Besancon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP