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Complete title: Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors
|Research Study Number||20111792|
|Principal Investigator||Shailender Bhatia, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study:Both
- Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
- Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
- Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
- Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- No other currently active malignancy.
- No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
- Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
- Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
- Corrected QT interval (QTc) = 450 msec at least 7 days prior to registration for protocol therapy.
- No clinically significant infections as judged by the treating investigator.
- No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
- No collecting duct, medullary or sarcomatoid histology.
- No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
- No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
- No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
- No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
- No grade 2 or greater peripheral neuropathy.
Other exclusion criteria may apply.
Genitourinary Cancer; Kidney Cancer; Renal Cancer; Solid Tumors
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