Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03592199
Previous Study | Return to List | Next Study

Biomarker Study of Pts With Metastatic ccRCC Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib (SuAx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592199
Recruitment Status : Active, not recruiting
First Posted : July 19, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Tracking Information
First Submitted Date  ICMJE December 27, 2017
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE December 11, 2017
Estimated Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation [ Time Frame: through study completion (up to 2 years) ]
First Line Response Rate (RR) With Sunitinib (RECIST 1.1) in patients with VEGF pathway mutation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 1sr line RR with Sunitinib [ Time Frame: through study completion (up to 2 years) ]
    First Line Response Rate (RR) with Sunitinib (RECIST 1.1)
  • 2nd Line RR with Axitinib [ Time Frame: through study completion (up to 2 years) ]
    Second Line Response Rate (RR) with Axitinib (RECIST 1.1)
  • 1st line PFS with Sunitinib [ Time Frame: through study completion (up to 2 years) ]
    First Line Progression Free Survival (PFS) with Sunitinib
  • 2nd PFS with Axitinib [ Time Frame: through study completion (up to 2 years) ]
    Second Line Progression Free Survival (PFS) with Axitinib
  • Overall Survival (OS) [ Time Frame: through study completion (up to 2 years) ]
    Overall Survival
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: through study completion (up to 2 years) ]
    CTCAE v.4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • 1sr line RR with Sunitinib [ Time Frame: through study completion (up to 2 years) ]
    First Line Response Rate (RR) with Sunitinib (RECIST 1.1)
  • 2nd Line RR with Axitinib [ Time Frame: through study completion (up to 2 years) ]
    Second Line Response Rate (RR) with Axitinib (RECIST 1.1)
  • 1st line PFS with Sunitinib [ Time Frame: through study completion (up to 2 years) ]
    First Line Progression Free Survival (PFS) with Sunitinib
  • 2nd PFS with Axitinib [ Time Frame: through study completion (up to 2 years) ]
    Second Line Progression Free Survival (PFS) with Axitinib
  • OS (Overall Survival) [ Time Frame: through study completion (up to 2 years) ]
    Overall Survival
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: through study completion (up to 2 years) ]
    CTCAE v.4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker Study of Pts With Metastatic ccRCC Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
Official Title  ICMJE Biomarker Study of Patients With Metastatic Clear Cell Renal Carcinoma (ccRCC) Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
Brief Summary This is a prospective single arm phase II study to evaluate potential prognostic and/or predictive biomarkers in patients with metastatic ccRCC undergoing treatment with 1st line sunitinib on a 4/2 schedule followed by axitinib on 2nd line therapy.
Detailed Description In this study, all included patients will receive sunitinib until disease progression and/or limiting toxicity. If patients develop toxicities ≥ Grade 2 on 50 mg per day 4 weeks-on / 2 weeks-off schedule, a modified schedule of 50 mg/day 2 weeks-on / 1 week-off will be offered. After disease progression on sunitinib, all eligible patients will receive axitinib 5 mg twice a day. The investigators plan to assess, by next generation sequencing, the prevalence of mutations in several cancer related genes in baseline archived tissue from the patients included in the study, and the potential correlations between these somatic mutations and anti-VEGF (Vascular Endothelial Growth Factor) therapy efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Clear Cell Renal Cell Carcinoma
Intervention  ICMJE Drug: Sunitinib
1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy
Other Name: Axitinib
Study Arms  ICMJE Experimental: 1st Line Sunitinib and 2nd Line Axitinib
1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 2, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
30
Estimated Study Completion Date  ICMJE December 11, 2022
Estimated Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer staging) renal cell carcinoma;
  • Histologic confirmed clear cell renal cell carcinoma;
  • No prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, everolimus or temsirolimus) for advanced or metastatic RCC;
  • Measurable disease by RECIST;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2;
  • Adequate organ system functions;
  • Patients must understand and be willing to sign the written informed consent form of this study.

Exclusion Criteria:

  • Non-clear cell renal cell carcinoma
  • Pregnant or lactating female.
  • History of another malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin carcinoma or successfully treated in situ carcinoma are eligible.
  • History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery) and meet all 3 of the following criteria are eligible:

    1. Are asymptomatic
    2. No evidence of active CNS metastases for ≥3 months prior to enrolment
    3. Have no requirement for steroids or anticonvulsants
  • Clinically significant gastrointestinal abnormalities including, but not limited to:

    1. Malabsorption syndrome
    2. Major resection of the stomach or small bowel that could affect the absorption of study drug
    3. Active peptic ulcer disease
    4. Inflammatory bowel disease
    5. Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
    6. History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days prior to beginning study treatment.
  • History of any one or more of the following cardiovascular conditions within the past 12 months:

    1. Cardiac angioplasty or stenting
    2. Myocardial infarction
    3. Unstable angina
    4. Symptomatic peripheral vascular disease
    5. Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
    6. History of cerebrovascular accident including transient ischemic attack (TIA).
    7. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) of ≥ 90 mmHg
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03592199
Other Study ID Numbers  ICMJE NP 1096/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date September 2019

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