Sutent Rechallenge In mRCC Patients

NCT01827254 | Completed Results DMC

• 2 other identifiers: A6181211ETUDE RESUME
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 18

Brief Summary

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

sutent rechallenge

Outcome Measures

Primary Outcomes (4)

• Progression Free Survival With Sunitinib as First Line of Therapy

  The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.

  From start of treatment up to 66.6 months

• Progression Free Survival for Re-challenge With Sunitinib

  The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.

  From start of treatment up to 52.2 months

• Progression Free Survival: Second Line of Treatment

  The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).

  From start of treatment up to 22.9 months

• Progression Free Survival: Third Line Treatment

  The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).

  From start of treatment up to 23.7 months

Secondary Outcomes (2)

• Overall Survival

  Baseline up to death or end of study (up to 98.0 months)

• Percentage of Participants With Objective Response

  Baseline up to 98.0 months

Other Outcomes (1)

• Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 24 months

Study Arms (1)

Non-Interventional Study

Other: sunitinib: observational study

Interventions

sunitinib: observational study OTHER

Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line

Also known as: sunitinib 50 mg 4/2

Non-Interventional Study

Eligibility Criteria

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

Study Population

mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line

You may qualify if:

• Histologically documented metastatic RCC containing predominantly clear cell component.
• Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
• At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
• At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
• Life expectancy of at least 3 months.

You may not qualify if:

• Patient who didn't receive Sunitinib in first line.
• Patient who received less than one line of treatment .

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

CHU de la Timone

Marseille, Cedex 5, 13335, France

Location

Hopital albert Michalon

Grenoble, Cedex 9, 38043, France

Location

Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, France, 42271, France

Location

Centre Paul Papin

Angers, 49100, France

Location

Hôpital Saint-André

Bordeaux, 33075, France

Location

Centre Catalan Urologie Andrologie

Cabestany, 66330, France

Location

Centre Oscar Lambret - Cancérologie Urologie Digestive

Lille, 59020, France

Location

clinique de la Louvière

Lille, 59042, France

Location

Hopital Dupuytren - Oncologie Medicale

Limoges, 87042, France

Location

Centre Leon Berard, Service d'Oncologie Medicale

Lyon, 69373, France

Location

Institut Paoli-Calmettes / Hôpital de jour

Marseille, 13273 Cedex 9, France

Location

Hopital Timone Adultes

Marseille, 13385, France

Location

Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Centre Rene Gauducheau - Service Oncologie Medicale

Saint-Herblain, 44805, France

Location

Institut Claudius Regaud

Toulouse, 31000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 9, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

FR (18)