First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma

Phase 1

• Conditions: ocally advanced or metastatic renal cell carcinoma; MedDRA version: 20.0Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001138-40-DE
• Lead Sponsor: iOMEDICO AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-08
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1.Histologically confirmed metastatic or locally advanced (defined as non operable tumor), predominantly clear cell renal cell carcinoma.
2.At least three of the following six predictors of short survival are required:
oLDH > 1.5 x ULN
oHemoglobin < LLN
ocorrected serum calcium level > 10 mg/dl (2.5 mmol/l)
otime from initial diagnosis of renal-cell carcinoma to occurrence of metastases of less than 1 year
oKarnofsky Status of 60 or 70
3.Karnofsky Status = 60
4.Age = 18 years or legal age of consent if greater than 18 years
5.Dated and signed written informed consent prior to performance of study-specific procedures or assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

- Other malignancy. (Patients who have undergone prior radical or partial nephrectomy for RCC are allowed). Subjects who have had another malignancy and have been disease-free for five years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- Prior systemic treatment for renal cell carcinoma. (NB: all treatments, neo-adjuvant, adjuvant or for locally advanced or metastatic RCC are not permitted.)
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography (CT) or magnetic resonance imaging (MRI) is required only if clinically indicated or if the subject has a history of CNS metastases.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
oActive peptic ulcer disease
oKnown intraluminal metastatic lesion/s with risk of bleeding
oInflammatory bowel disease (e.g. ulcerative colitis, Chrohn’s disease), or other gastrointestinal conditions with increased risk of perforation
oHistory of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
- History of any one or more of the following cardiovascular conditions within the past 6 months:
oMyocardial infarction
oCardiac angioplasty or stenting
oUnstable angina
oCoronary artery bypass graft surgery
oSymptomatic peripheral vascular disease
oClass III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension (defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg). Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions at intervals of at least one hour if it is not <140/90 mmHg at baseline assesment. On each of these occasions, SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
- Pregnant or breast-feeding women
- Known hypersensitive reaction to any of the components of study treatments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary analysis will focus on the rate of poor risk patients as defined by the MSKCC criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib. ;Secondary Objective: - Estimate the progression free survival of patients treated with pazopanib <br>- To assess overall survival of poor risk patients treated with pazopanib.<br>- To assess the overall response rate (ORR) according to RECIST-criteria 1.1 and the duration of response<br>- To assess the safety profile of pazopanib in first line poor risk patients<br>;Primary end point(s): Rate of poor risk patients as defined by the MSKCC criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib. ;Timepoint(s) of evaluation of this end point: 6 months (26 weeks)