Phase 2
Completed N=60
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
Genitourinary Cancer · Kidney Cancer
Source: ClinicalTrials.gov NCT02060370 ↗
Enrolled (actual)
60
Serious AEs
59.3%
Results posted
Feb 2020
Primary outcomePrimary: Rate of Toxicity — 15; 8; 5; 3 Participants
Summary
The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Toxicity |
15; 8; 5; 3 | — |
| SECONDARY Progression-Free Survival (PFS) |
13.7 | — |
| SECONDARY The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event |
35; 1; 6; 1; 5; 8 | — |
| SECONDARY Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities |
7; 14; 3; 5 | — |
| SECONDARY Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G) |
87.8; 88; 86; 89; 86.8; 79.5 | — |
| SECONDARY Changes in Circulating DNA Levels With Antiangiogenic Treatment |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
- Age >/=18 years
- Measurable or evaluable metastatic disease per RECIST v 1
- ECOG performance status 0-1
- Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) /= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium 6 months prior to registration and therapy not discontinued for toxicity)
- Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)
- Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Current treatment on another therapeutic clinical trial
- Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding
- Pregnant or breastfeeding women are excluded from this study because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib. Breastfeeding must be discontinued if the mother is treated with sunitinib
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy
Data sourced from ClinicalTrials.gov (NCT02060370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.