BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

Completed · Phase 1/Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.

Key facts

Study ID: NCT01034631
Run by: Hoosier Cancer Research Network
People needed: 154
Starts: 2010-01-01
Expected to finish: 2016-12-01
Last updated by the study team: 2022-07-11

Who can join

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

You may qualify if…

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.

You may not qualify if…

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 ≥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, 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.

Where it is running

Genesis Cancer Center — Hot Springs, Arkansas, United States
Providence Health System: Roy and Patricia Disney Family Cancer Center — Burbank, California, United States
Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
Compassionate Cancer Care Medical Group — Corona, California, United States
City of Hope — Duarte, California, United States
Robert A. Moss, M.D., FACP, Inc. — Fountain Valley, California, United States
California Cancer Associates for Research and Excellence — Fresno, California, United States
Marin Specialty Care — Greenbrae, California, United States
Good Samaritan Hospital — Los Angeles, California, United States
UCLA Med - Hematology & Oncology — Los Angeles, California, United States
Compassionate Cancer Care Medical Group — Riverside, California, United States
American Institute of Research — Whittier, California, United States
Centura Health Research Center — Denver, Colorado, United States
Western Oncology & Hematology — Golden, Colorado, United States
Cancer Care Centers of Florida: Brooksville — Brooksville, Florida, United States
Broward Oncology Associates — Fort Lauderdale, Florida, United States
University of Florida, Shands Cancer Center — Gainesville, Florida, United States
Cancer Specialists of North Florida — Jacksonville, Florida, United States
Advanced Pharma CR, LLC — Miami, Florida, United States
Cancer Care Centers of Florida — New Port Richey, Florida, United States
Ocala Cancer Institute — Ocala, Florida, United States
Cancer Care Centers of Brevard — Rockledge, Florida, United States
Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
Dublin Hematology & Oncology Care — Dublin, Georgia, United States
Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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