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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

Thank you

Trial Information

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


OUTLINE: This is a multi-center study.

Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design,
21-day cycle

- Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2

- Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2

- Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2

- Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2

Phase II: Patients will be randomized 1:1 to Arm A or Arm B

Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle

Sequential Arm B: Everolimus 10 mg 21 day cycle

- Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or
intolerable toxicity on everolimus therapy.

Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol
therapy.

Life Expectancy: Not specified

Hematopoietic:

- White blood cell count (WBC) > 3.5 K/mm3

- Hemoglobin (Hgb) > 8.5 g/dL

- Platelets > 100 K/mm3

- Absolute neutrophil count (ANC) > 1.5 K/mm3

Hepatic:

- Total Bilirubin < 1.25 x ULN

- Aminotransferase (AST and ALT) < 2.5 x ULN

Renal:

- Serum Creatinine < 2.5 x ULN (upper limit normal)

Cardiovascular:

- 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.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To determine maximum tolerated dose and toxicities of BNC105P in combination with everolimus.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Thomas Hutson, D.O.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

HOG GU09-145

NCT ID:

NCT01034631

Start Date:

January 2010

Completion Date:

June 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Metastatic Kidney Cancer
  • BNC105P
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Mount Nittany Medical CenterState College, Pennsylvania  16803
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan  49546
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
City of HopeDuarte, California  91010
Genesis Cancer CenterHot Springs, Arkansas  71913
Cascade Cancer CenterKirkland, Washington  98034-3013
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
Tufts Medical CenterBoston, Massachusetts  02111
Methodist Cancer CenterOmaha, Nebraska  68114
Texas Oncology, PADallas, Texas  75246-2006
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Somerset Hematology Oncology AssociatesSomerset, New Jersey  08873
Hematology and Oncology Associates of Rhode IslandCranston, Rhode Island  02920
Kentucky Cancer ClinicPikeville, Kentucky  41501
Allegheny Cancer CenterPittsburgh, Pennsylvania  15212-4772
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Rockwood ClinicSpokane, Washington  99220
Metairie OncologistsMetairie, Louisiana  70006
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Center of KansasWichita, Kansas  67214
New York Oncology Hematology, PCAlbany, New York  12208
Robert A. Moss, M.D., FACP, Inc.Fountain Valley, California  92708
Lynchburg Hematology Oncology Clinic, Inc.Lynchburg, Virginia  24501
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Compassionate Cancer Care Medical GroupCorona, California  92882
South Carolina Cancer SpecialistsHilton Head Island, South Carolina  29925
Medical Oncology LLCBaton Rouge, Louisiana  70809
MUSC Hollings Cancer CenterCharleston, South Carolina  29425
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Berks Hematology Oncology AssociatesWest Reading, Pennsylvania  19611
Community Regional Cancer CenterIndianapolis, Indiana  46256
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Kootenai Cancer CenterPost Falls, Idaho  83854
Northwestern University, Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611
Mercy Physicians of OklahomaTulsa, Oklahoma  74136
The Jones Clinic, PcGermantown, Tennessee  38138
Presbyterian Medical GroupAlbuquerque, New Mexico  87110
Hematology Oncology Associates of RocklandNyack, New York  10960
Signal Point Clinical Research CenterMiddletown, Ohio  45042
Monroe Medical AssociatesMunster, Indiana  46321
Purchase Cancer GroupPaducah, Kentucky  42002
Good Samaritan HospitalLos Angeles, California  90017
Methodist Hospital Research InstituteHouston, Texas  77030
Ocala Cancer InstituteOcala, Florida  34471
Gettysburg Cancer CenterGettysburg, Pennsylvania  17325
CTRC at the UT Health Science Center at San AntonioSan Antonio, Texas  78229
University of Florida, Shands Cancer CenterGainesville, Florida  32610
IU Health GoshenGoshen, Indiana  46527
IU Health Central Indiana Cancer CentersIndianapolis, Indiana  46219
Horizon Oncology ResearchLafayette, Indiana  47905
IU Health at Ball Memorial Hospital Cancer CenterMuncie, Indiana  47303
Siouxland Hematology Oncology Associates, LLP, Nylen Cancer CenterSioux City, Iowa  51101
Metro Health Cancer CareWyoming, Michigan  49519
University of New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87131
Tisch Cancer Institute at Mount Sinai Medical CenterNew York, New York  10029
Houston Cancer CenterHouston, Texas  77055
Harrison HealthPartners Bremerton Hematology & OncologyBremerton, Washington  98310
University of Washington, Seattle Cancer Care AllianceSeattle, Washington  98109
Group Health Medical CentersSeattle, Washington  98109
University of Wisconsin, Clinical Cancer CenterMilwaukee, Wisconsin  53226
Cancer Care Centers of BrevardRockledge, Florida  32955
American Institute of ResearchWhittier, California  90603
Sletten Cancer SpecialistsGreat Falls, Montana  59405
Cancer Care Centers Of FloridaBrooksville, Florida  34613
Providence Health System: Roy and Patricia Disney Family Cancer CenterBurbank, California  91505
California Cancer Associates for Research and ExcellenceFresno, California  93720
Marin Specialty CareGreenbrae, California  94904
UCLA Med - Hematology & OncologyLos Angeles, California  90095
Centura Health Research CenterDenver, Colorado  80210
Western Oncology & HematologyGolden, Colorado  80401
Cancer Care Centers of Florida: BrooksvilleBrooksville, Florida  34613
Cancer Specialists of North FloridaJacksonville, Florida  32256
Advanced Pharma CR, LLCMiami, Florida  33136
Dublin Hematology & Oncology CareDublin, Georgia  31021
Edward H. Kaplan, M.D., & AssociatesSkokie, Illinois  60076
Deaconess ClinicEvansville, Indiana  47713
Bozeman Deaconness Cancer CenterBozeman, Montana  59715
Trinitas Regional Medical CenterElizabeth, New Jersey  07202
NYU Langone Arena OncologyLake Success, New York  11042
First Health of the CarolinasPinehurst, North Carolina  28374
Lawrence M. Stallings, M.D.Wooster, Ohio  44691
Willamette Valley Cancer InstituteSpringfield, Oregon  97477
Texas Oncology: Austin NorthAustin, Texas  78758
Texas Oncology: BedfordBedford, Texas  76022
Texas Oncology: Fort WorthFort Worth, Texas  76104
Texas Oncology: Houston Memorial CityHouston, Texas  77024