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

NCT03592199 | Unknown Phase 2

• 1 other identifier: NP 1096/17
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

biomarker; metastatic; sunitinib; axitinib; next generation sequencing; clear cell renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation

  First Line Response Rate (RR) With Sunitinib (RECIST 1.1) in patients with VEGF pathway mutation

  through study completion (up to 2 years)

Secondary Outcomes (6)

• 1sr line RR with Sunitinib

  through study completion (up to 2 years)

• 2nd Line RR with Axitinib

  through study completion (up to 2 years)

• 1st line PFS with Sunitinib

  through study completion (up to 2 years)

• 2nd PFS with Axitinib

  through study completion (up to 2 years)

• Overall Survival (OS)

  through study completion (up to 2 years)

Study Arms (1)

1st Line Sunitinib and 2nd Line Axitinib

EXPERIMENTAL

1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy

Drug: Sunitinib

Interventions

Sunitinib DRUG

1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy

Also known as: Axitinib

1st Line Sunitinib and 2nd Line Axitinib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Are asymptomatic
• No evidence of active CNS metastases for ≥3 months prior to enrolment
• Have no requirement for steroids or anticonvulsants
• Clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel that could affect the absorption of study drug
• Active peptic ulcer disease
• Inflammatory bowel disease
• Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
• 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:

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Pfizer: collaborator

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, 01246000, Brazil

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Sunitinib; Axitinib

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; 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; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles

Study Design

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

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: July 19, 2018
• Study Start: December 11, 2017
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2022
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

BR (1)