Phase II Study of Pazopanib as Second-line Treatment After Sunitinib in mRCC Patients

NCT02324803 | Unknown Phase 2 DMC

• 1 other identifier: SUCC001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

assess the activity and toxicity of second-line treatment with pazopanib after failure of first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to pazopanib in mRCC patients.

Conditions

Self Efficacy; Adverse Drug Event; Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  pazopanib treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled

Secondary Outcomes (3)

• Overall survival of patients treated with second-line pazopanib therapy

  Initiation of pazopanib dose until death, assessed up to 30 months after the last patient has been enrolled

• Objective Response Rate to pazopanib therapy

  Initiation of pazopanib treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled

• Number of grade 3 or 4 adverse events attributable to pazopanib

  Time of first dose of pazopanib to approximately one month after discontinuation of pazopanib

Study Arms (1)

pazopanib once daily

EXPERIMENTAL

Patients received continuous treatment of 800 mg pazopanib once daily until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Dose reductions by 400 mg to a lowest dose of 200 mg daily were allowed on the basis of tolerability and according to protocol-defined guidelines.

Drug: pazopanib

Interventions

pazopanib DRUG

continuous treatment of 800 mg pazopanib once daily until disease progression

Also known as: Votrient

pazopanib once daily

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• Diagnosis of renal cell carcinoma with clear-cell component histology.
• Locally advanced/metastatic renal cell carcinoma
• Measurable lesion (RECIST 1.1) on physical exam or as CT/MRI
• No prior systemic therapy for advanced/metastatic RCC
• Karnofsky performance scale \>=70
• Age \>=18 years
• A female is eligible to enter and participate in this study if she is of: non-childbearing/agrees to use adequate contraception
• A male with female partner of childbearing potential must have vasectomy/agree to use effective contraception from two weeks prior to administration of the 1st dose of study treatment for a period of time after the last dose of study treatment
• Adequate organ function
• Able to swallow and retain orally administered medication and must not have clinically significant GIT abnormalities that may alter absorption
• The date of disease progression must be within six months of stopping sunitinib or during treatment with sunitinib
• Measurable lesion at pazopanib baseline as per the RECIST 1.1 criteria

You may not qualify if:

• Pregnant/lactating
• History of another malignancy (unless have been disease-free for 3 years)
• History or clinical evidence of Central nervous system metastases (unless have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 month time interval.
• 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, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess
• Moderate to severe hepatic impairment (Child-Pugh Class C)
• Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
• Subjects receiving chronic treatment with corticosteroids/other immunosuppressive agents
• Subjects with a known history of HIV seropositivity
• Subjects with active bleeding, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
• Presence of any severe or uncontrolled medical conditions/infection.
• Currently receiving chemotherapy, immunotherapy or radiotherapy
• Corrected QT interval (QTc) \> 480 milliseconds
• History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
• Poorly controlled hypertension (defined as systolic blood pressure of \>=140mmHg or diastolic blood pressure of \>=90mmHg).
• History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless recent DVT have been treated with therapeutic anti-coagulating agents for at least 6 weeks)

Sponsors & Collaborators

• Southern China Urology Cancer Consortium: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; 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

Study Officials

• Mian Xie

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mian Xie

CONTACT

862083062956; mianxie@gird.cn

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 13, 2014
• First Posted: December 24, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

CN (1)