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Clinical Trials/NL-OMON39600
NL-OMON39600
Completed
Phase 2

A randomized phase II study to explore the efficacy and feasibility of upfront bi-monthly rotations between Everolimus and Pazopanib with sequential treatment of first line Pazopanib and second line Everolimus until progression in patients with advanced or metastatic clear cell renal cancer. - ROPETAR

Werkgroep Immunotherapie Nederland voor Oncologie0 sites100 target enrollmentTBD
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Conditions10038364Kidney cancerRenal cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
10038364
Sponsor
Werkgroep Immunotherapie Nederland voor Oncologie
Enrollment
100
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Werkgroep Immunotherapie Nederland voor Oncologie

Eligibility Criteria

Inclusion Criteria

  • •\- Subjects must provide written informed consent prior to performance of study\-specific procedures or assessments, and must be willing to comply with treatment and follow\-up.;\- Age \>\= 18 years.;\- Histologically confirmed diagnosis of progressive metastatic clear cell renal cell cancer defined as \>10% of the tumor cells having the clear cell phenotype.;\- Locally advanced (defined as disease not amenable to curative surgery or
  • •radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to AJCC staging).;\- Eastern Cooperative Oncology Group (ECOG) performance status of 0\-2\.;\- Measurable disease. ;\- No prior systemic anti\-cancer treatment against clear cell renal cancer.;\- Adequate organ system function.;\- A female is eligible to enter and participate in this study if she is of: Non\-childbearing potential (physiologically or by using adequate contraception) .

Exclusion Criteria

  • •\- Malignancy within the previous 5 years.;\- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.;\- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • •1\)Active peptic ulcer disease.
  • •2\)Known intraluminal metastatic lesions with risk of bleeding.
  • •3\) Inflammatory bowel disease (e.g. ulcerative colitis, Crohn\*s disease), or other gastrointestinal conditions with increased risk of perforation.
  • •4\)History of abdominal fistula, gastrointestinal perforation, or intra\-abdominal abscess within 28 days prior to beginning study treatment.;\-Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
  • •1\)Malabsorption syndrome.
  • •2\)Major resection of the stomach or small bowel.;\-Presence of uncontrolled infection.;\-Known past or present infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human
  • •Immunodeficiency Virus (HIV).;\-Corrected QT interval (QTc) \> 480 msecs using Bazett\*s formula.;\-History of one or more of the following cardiovascular conditions within the past 6 months:
  • •1\)Cardiac angioplasty or stenting
  • •2\)Myocardial infarction

Outcomes

Primary Outcomes

Not specified

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