Biomarker Study of Pts With Metastatic ccRCC Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
NCT03592199
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Adult Trials: 18+ Years
- 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.
- 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
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| 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 | 7 | ||||||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| 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 |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| 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 | |||||||