Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

NCT02689167 | Unknown Phase 2

• 1 other identifier: P/2015/254
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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 "

Conditions

Kidney Neoplasms; Metastatic Renal Cell Cancer

Keywords

renal cell carcinoma; sunitinib; metastatic; schedule; toxicity; safety

Outcome Measures

Primary Outcomes (1)

• MDT (median duration of treatment)

  The primary objective of this study is to estimate the median duration of treatment in each treatment group (arm A vs arm B) calculated from sunitinib initiation.

  12 mo

Secondary Outcomes (7)

• PFS (progression-free survival)

  12 months

• OS (overall survival)

  30 months

• duration of sunitinib post randomization

  12 months

• time to randomization

  4 months

• ORR (objective response rate)

  6 months

Study Arms (2)

Arm A 4/6

ACTIVE COMPARATOR

Sunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "

Drug: Sunitinib

Arm B 2/3

EXPERIMENTAL

Sunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "

Drug: Sunitinib

Interventions

Sunitinib DRUG

Arm A 4/6; Arm B 2/3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Major surgery within 4 weeks before sunitinib initiation
• 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Pfizer: collaborator

Study Sites (1)

CHU Besancon

Besançon, Franche-Comté, 25030, France

Location

Related Publications (1)

• Mouillet G, Paillard MJ, Maurina T, Vernerey D, Nguyen Tan Hon T, Almotlak H, Stein U, Calcagno F, Berthod D, Robert E, Meurisse A, Thiery-Vuillemin A. Open-label, randomized multicentre 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: study protocol of the SURF trial. Trials. 2018 Apr 12;19(1):221. doi: 10.1186/s13063-018-2613-8.

  PMID: 29650037 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• antoine thiery-vuillemin, MD PhD

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 23, 2016
• Study Start: February 19, 2016
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)