A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma

Stopped early · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™ (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle), to subjects with refractory renal cell carcinoma (RCC) until the disease progresses. Subjects who have failed 3 prior treatments for RCC including vascular endothelial growth factor (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that cannot be surgically removed will be eligible for screening.

Key facts

Study ID

NCT01762033

Run by

Lpath, Inc.

People needed

40

Starts

2013-02-01

Expected to finish

2015-09-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable, locally advanced recurrent or metastatic RCC
• Histological or cytological confirmation of clear cell RCC - core tissue biopsy of either primary tumor or metastatic lesion with paraffin-embedded tissue specimens if no prior nephrectomy
• Measurable disease by RECIST 1.1
• Had one prior therapy for unresectable RCC with a VEGF/VEGFR targeted therapy (sunitinib, sorafenib, other VEGFR TKI or bevacizumab) - One prior treatment with an mTOR inhibitor (everolimus, temsirolimus or sirolimus) for unresectable disease permitted-Prior immunotherapy (immunomodulators such as cytokines, interleukins, vaccines, etc.) such as IL-2 also permitted
• Male or non-pregnant, non-nursing female
• Life expectancy ≥3 months
• ECOG performance status of 0, 1 or 2
• Must not be receiving any concurrent anticancer therapy
• Baseline CT or MRI scans of measurable disease sites by RECIST 1.1 performed within 2 weeks of Day 0 - For subjects with bone metastases, baseline bone scan performed within 4 weeks of study entry
• Adequate organ and immune function (within 7 days of Day 0):
• Hemoglobin >9 g/dL-Absolute neutrophil count >1500 cells/uL without growth factors-Platelet count ≥100x10\^9/L without transfusion-Serum creatinine <2.0x ULN or creatinine clearance >40 mL/min-Total bilirubin <1.5x ULN-AST/ALT <2.5x ULN (or <5.0x ULN if liver metastases present)-INR and aPTT <1.5x ULN
• Subject lesions for arterial spin labeling (ASL) MRI ≥2.5cm by CT imaging
• Must understand, be able and willing to fully comply with study procedures

You may not qualify if…

• Prior treatment with >3 VEGF pathway and/or mTOR inhibitors for RC cancer
• History of other CNS disease (spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis)
• Major surgery within 4 weeks of Day 0
• Radiation therapy within 4 weeks of baseline/infusion. Prior palliative radiation to metastatic lesions is acceptable if there is at least one measurable, non-radiated lesion
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 0
• Known or suspected intolerance or hypersensitivity to study materials or any excipients
• Evidence of bowel obstruction because of theoretical possibility of GI perforation with an anti-angiogenesis agent
• Severe hemorrhage within 4 weeks of screening
• History of GI perforation
• History of non-healing wounds including ulcer or delayed bone fractures
• Prolonged QTc interval on baseline ECG (>450 msec for males or >470 msec for females), cardiac dysrhythmias including atrial fibrillation, torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG
• Secondary malignancy within the last 5 years, except for adequately-treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
• Previously enrolled in an sonepcizumab study or into this study and subsequently withdrawn
• History of alcohol or other substance abuse within the last year
• Use of corticosteroids or other immunosuppression (if taking systemic steroids [vs. topical], at least 4 weeks must have passed since the last dose)
• Growth factors within 1 week of screening
• Serious medical conditions that might be aggravated by treatment or limit compliance
• Cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6 months prior to screening
• Participation in another clinical trial
• Other severe or intercurrent acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — Inverness, Florida, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Tennessee Oncology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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