Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine KinaseInhibitors. Hoosier Oncology Group GU09-145
- Conditions
- Clear cell renal cell carcinomaCancer - Kidney
- Registration Number
- ACTRN12613000063718
- Lead Sponsor
- Bionomics Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 134
Written informed consent and HIPAA authorization for release of personal
health information.
NOTE: HIPAA authorization may be included in the informed consent orobtained separately.
Age > or equal to 18 years at the time of consent.
Karnofsky Performance Score (KPS) > or equal to 70 within 7 days prior to registration for protocol therapy.
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 8 weeks after treatment discontinuation.
Females of childbearing potential must have a negative pregnancy test
within 7 days prior to registration for protocol therapy. NOTE:
Females are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or they are postmenopausal.
Females must not be breastfeeding.
Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma). NOTE: No component of collecting duct or medullary histology is allowed. Up to 30% sarcomatoid histology will be permitted.
Metastatic or locally advanced unresectable RCC. NOTE: Prior
nephrectomy is not mandatory
Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors
(TKIs). NOTE: Patients who did not tolerate a VEGF-directed TKI may also be considered for entry to the trial. The Sponsor is to be consulted in such cases.
Prior treatment with more than 2 VEGF-directed TKIs will be permitted
in the phase I component of the study.
Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
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.
At least 30 days must have elapsed prior to registration following major
surgery (opening of a body cavity – chest, abdomen or cranium), or at least 7 days prior to registration for minor surgery.
Prior radiation therapy to <25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if
completed within 14 days prior to registration for protocol therapy.
Corrected QT interval (QTc) < or equal to 450 msec within 7 days prior to registration
for protocol therapy. NOTE: if (QTc) is >450 and < or equal to 500 msec, subject to local cardiology review and approval, the patient may be enrolled if the QTc elevation is deemed clinically insignificant.
NOTE: Laboratory values must be obtained within 7 days prior to
registration for protocol therapy.
White blood cell count (WBC) >or equal to 3.5 K/ mm3
Hemoglobin (Hgb) > or equal to 8.5 g/dL
Platelets > or equal to 100 K/ mm3
Absolute neutrophil count (ANC) > or equal to 1.5 K/ mm3
Serum Creatinine <2.5 x ULN (upper limit normal)
Total Bilirubin < and equal to 1.25 x ULN
Aminotransferase (AST and ALT) < or equal to 2.5 × ULN
INR <1.5
No clinically significant infections as judged by the treating investigator
No liver disease such as cirrhosis, chronic active hepatitis or chronic
persistent hepatitis
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. In those cases where everolimus is being used immediately prior to study entry, a washout period will not be required.
No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
NOTE: Low dose warfarin for catheter prophylaxis or acetylsalicylic acid < equal to 325 mg/day is acceptable.
No uncontrolled hypertension, BP >150/100mmHg despite use of antihypertensive medication(s).
No thrombotic event within 6 months (deep vein thrombosis, pulmonary
embolism) of registration for protocol therapy.
No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30
days prior to registration for protocol therapy.
No grade 2 or greater peripheral neuropathy.
No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy.
NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis > or equal to 30 days prior to registration for
protocol therapy, are off steroids, and are asymptomatic.
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 patients AE must be resolved back to baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in 6-month progression free survival (PFS) with the addition of BNC105P to everolimus.<br>Recist defined tumor assessment. Measurement from the start of the treatment until the criteria for disease progression is met (or death occurs), taking as reference the smallest measurements recorded since the treatment started. The time to progression, in patients with documented disease progression at their first disease evaluation, will be considered the time between initiation of therapy and the date of first documentation of disease progression. The percentage of patients whom have achieved Progression Free Survival (PFS) at 6 months will be calculated.[Every 9 weeks for 2 years from registration for protocol therapy, every 6 months for years 3 - 5 for up to a<br>maximum of 5 years from registration to protocol therapy]
- Secondary Outcome Measures
Name Time Method