DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

The primary objective of this study is:

• To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer

The secondary objectives of this study are:

• To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
• To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
• A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: calcitriol

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N2
      • Tom Baker Cancer Center-Medical Oncology
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • BCCA-Centre for the Southern Interior
    • Vancouver, British Columbia, Canada, V5Z4E6
      • BCCA-Vancouver
    • Victoria, British Columbia, Canada, V8R 6V5
      • British Columbia Cancer Agency - Vancouver Island Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E0V9
      • Cancer Care Manitoba
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital (SERHA)
    • Moncton, New Brunswick, Canada, EIC8X3
      • Dr. Leon Richard Oncology Center
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Centre for Clinical Research Cancer Care Program
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Jaravinski Cancer Centre Hamilton Health Services
    • Kingston, Ontario, Canada, K7L 5P9
      • Cancer Centre of Southeastern Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Regional Cancer Centre
    • Sudbury, Ontario, Canada, P3E 5J1
      • Regional Cancer Program de l'Hopital Regional de Sudbury
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Czech Republic
  • Prague, Czech Republic, 180 81
    • Institute of Radiation Oncology of Teaching Hospital Na Bulovce
  • Prague, Czech Republic
    • Department of Radiation and Oncology of Teaching Hospital Motol
  • Prague, Czech Republic
    • Teaching Hospital Královské Vinohrady
• Former Serbia and Montenegro
  • Belgrade, Former Serbia and Montenegro, 18000
    • Clinical Center Niš - Clinic of Urology
• Germany
  • Augsburg, Germany, 86150
    • Gemeinschaftspraxis für Hämatologie & Onkologie
  • Bad Schwartau, Germany, 23611
    • Facharzt f. Urologie
  • Bautzen, Germany, 02625
    • Urologische Praxis
  • Berlin, Germany, 10117
    • Universitatsmedizin Charité
  • Berlin, Germany, 10967
    • Klinik am Urban
  • Berlin, Germany, 12200
    • Universitätsmedizin Charité Campus Benjamin Franklin
  • Berlin, Germany
    • Urologische Praxis
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig
  • Cottbus, Germany, 03046
    • Facharzt f. Urologie
  • Dresden, Germany, 01307
    • Urologische Klinik
  • Düsseldorf, Germany, 40225
    • Universitäsklinikum Düsseldorf
  • Düsseldorf, Germany, 40225
    • Urologische Klinik der Universitätsklink Düsseldorf
  • Essen, Germany
    • Universitätsklinikum Essen
  • Fulda, Germany, 36043
    • Klinikum Fulda, Urologische Klinik
  • Hagenow, Germany
    • Urologische Praxis
  • Hamburg, Germany, 22399
    • Urologische Gemeinschaftspraxis
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Nationales Centrum für Tumorerkrankungen
  • Homburg, Germany
    • Universitätsklinikum Homburg/Saar
  • Kassel, Germany, 34125
    • Klinikum Kassel GmbH
  • Kirchheim/Teck, Germany, 73230
    • Gemeinschaftspraxis für Urologie
  • Leipzig, Germany
    • Gesellschaft f. klinische Studien und Urologisches Gesundheitszentrum
  • München, Germany, 81675
    • Oberarzt d. Urolog. Abteilung
  • Münster, Germany, 48149
    • Obearzt der Urologischen Klinik, Universitätsklinik Münster
  • Wilhelmshaven, Germany, 26389
    • Praxisgemeinschaft für Onkologie und Urologie
  • Wuppertal, Germany, 42103
    • Gemeinschaftspraxis f. Urologie
  • Zwickau, Germany
    • Urologische Praxis
  • 50931
    • Köln, 50931, Germany
      • Universitätsklinikum Köln
• Hungary
  • Budapest, Hungary, 1071
    • IRM Center Hospital and Institutes, II.Department of Oncology
  • Budapest, Hungary, H-1145
    • Uzsoki Hospital of the Local Authority of Budapest, Oncoradiology
  • Debrecen, Hungary, H4032
    • University of Debrecen, Medical and Health Science Center, Department of Oncology
  • Szeged, Hungary
    • University of Szeged, Szent-Györgyi Albert Medical and Pharmacist Science Center, Clinic of Oncotherapy
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • San Juan VA Medical Center, Reseach Dept
• Romania
  • Arad, Romania, 310175
    • Cabinetul de Urologie
  • Brasov, Romania, 500366
    • Policlinica de Diagnostic Rapid
  • Bucuresti, Romania
    • Institutul Oncologic Bucuresti
  • Cluj Napoca, Romania, 400046
    • Euro S.R.L.
  • Constanta, Romania, 900635
    • ProVita 2000
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Theaching Hospital of F.D. Roosevelt
  • Martin, Slovakia, 03659
    • Faculty Hospital Martin
  • Presov, Slovakia
    • Faculty Hospital of J. A. Reiman
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223
      • Birmingham Hematology & Oncology Associates, LLC
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Clinical Research Center
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Hematology Associates - AOA
    • Scottsdale, Arizona, United States, 85260
      • Premiere Oncology of Arizona
    • Sedona, Arizona, United States, 86336
      • Northern Arizona Hematology & Oncology Associates, AOA
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Healthcare System
    • Tucson, Arizona, United States, 85724
      • U of Arizona / Arizona Cancer Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Beverly Hills, California, United States, 90211-1850
      • Tower Cancer Research Foundation
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute, Inc.
    • Los Angeles, California, United States, 90095-1738
      • UCLA Department of Urology
    • Martinez, California, United States, 94553
      • Veterans Affairs Northern California Health Care System
    • Modesto, California, United States, 95355
      • Sutter Gould Medical Foundation
    • Monterey, California, United States, 93940
      • Monterey Bay Oncology
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Center at
    • Sacramento, California, United States, 95816
      • Sutter Cancer Center
    • Sacramento, California, United States, 95817
      • UCD Cancer Center-Clinical Trials
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Rocky Mountain Cancer Centers
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Lombardi Cancer Center
  • Florida
    • 14529 Cortez Blvd., Florida, United States, 34613
      • Pasco Hernando Oncology Associates, P.A.
    • Deerfield Beach, Florida, United States, 33064
      • North Broward Medical Center
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Ft. Lauderdale, Florida, United States, 33308
      • Broward Oncology Associates
    • Ft. Lauderdale, Florida, United States, 33308
      • Michael and Dianne Bienes Comprehensive Cancer Center
    • Gainesville, Florida, United States, 32605
      • Gainesville Hematology Oncology Associates
    • Gainesville, Florida, United States, 32611
      • University of Florida Shands Cancer Center
    • Jacksonville, Florida, United States, 32256
      • Integrated Community Oncology Network
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center, U of Miami
    • N. Miami Beach, Florida, United States, 33179
      • Innovative Medical Research of South Florida Inc.
    • New Port Richey, Florida, United States, 34655
      • Florida Cancer Institute
    • New Port Richey, Florida, United States, 34652
      • Pasco Hernando Oncology Associates P.A.
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
    • Ocoee, Florida, United States, 34761
      • Cancer Centers of Florida, P.A.
    • Trinity, Florida, United States, 34655
      • AYS Urology
  • Georgia
    • Albany, Georgia, United States, 31701
      • Phoebe Cancer Center
    • Athens, Georgia, United States, 30607
      • Northeast Georgia Cancer Care, LLC
    • Atlanta, Georgia, United States, 30342
      • Atlanta Cancer Care
    • Atlanta, Georgia, United States, 30309
      • Peachtree Hematology-Oncology Consultants, PC
    • Gainesville, Georgia, United States, 30501
      • Northeast GA Medical Center
    • Tucker, Georgia, United States, 30084
      • Georgia Cancer Specialist
    • Valdosta, Georgia, United States, 31602
      • South Georgia Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Hematology Oncology Associates of Illinois
    • Chicago, Illinois, United States, 60640
      • Midwest Prostate & Urology Health Center
    • Niles, Illinois, United States, 60714
      • Cancer Care & Hematology Specialists of Chicagoland
    • Park Ridge, Illinois, United States, 60068
      • Oncology Specialists
    • Rockford, Illinois, United States, 61104
      • Swedish American Regional Cancer Center
    • Skokie, Illinois, United States, 60077
      • Hematology Oncology Associates of Illinois, L.L.C
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Central Indiana Cancer Centers
    • Muncie, Indiana, United States, 47303
      • Medical Consultants, PC c/o Ball Cancer Center
    • South Bend, Indiana, United States, 46601
      • Northern Indiana Cancer Research Consortium
    • Terre Haute, Indiana, United States, 47802
      • Hope Center
    • Vincennes, Indiana, United States, 47591
      • Medical Center of Vincennes
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Iowa Cancer Care
    • Mason City, Iowa, United States, 50401
      • Mercy Medical Center, North Iowa
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology-Oncology Associates
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Hematology Oncology Life Center
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Center for Cancer Medicine & Blood Disorders
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Health System
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, P.A.
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
    • Minneapolis, Minnesota, United States, 55407
      • MN Cooperative Group Outreach Prg.
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Institute
    • St. Louis Park, Minnesota, United States, 55416
      • Park Nicollet Institute
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Cancer Associates
    • Columbia, Missouri, United States, 65203
      • University of Missouri, Ellis Fischel Cancer Center
    • St. Joseph, Missouri, United States, 64507
      • St. Joseph Oncology, Inc.
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology-Oncology, PC
    • Omaha, Nebraska, United States, 68144
      • Nebraska Methodist Hospital - Oncology Research Dept
    • Scottsbluff, Nebraska, United States, 69361
      • Horizon's West Medical Group
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89135
      • Nevada Cancer Institute
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • UMDNJ-Newark
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital
    • Summit, New Jersey, United States, 07901
      • Overlook Oncology Center
  • New Mexico
    • Sante Fe, New Mexico, United States, 87505
      • New Mexico Cancer Care Associates
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • New City, New York, United States, 10956
      • Hematology Oncology Associates of
    • New York, New York, United States, 10021
      • Memorial Sloan-Kett
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14623
      • Interlakes Foundation Inc.
    • Staten Island, New York, United States, 10304
      • Staten Island Urological Research, PC
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Raleigh Hematology Oncology Associates
    • Fayetteville, North Carolina, United States, 28304
      • Carolina Cancer Management, Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Hematology Oncology Associates, PLLC
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Dakota Cancer Institute
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc.
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43213
      • Mid Ohio Oncology/Hematology, Inc.
    • Kettering, Ohio, United States, 45409
      • Dayton Oncology & Hematology, P.A.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Cancer Care Associates
    • Tulsa, Oklahoma, United States, 74136
      • Cancer Care Associates
  • Oregon
    • Eugene, Oregon, United States, 97401-8122
      • Willamette Valley Cancer Center
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
      • Consultants in Medical Oncology & Hematology
    • Dunmore, Pennsylvania, United States, 18512
      • Hematology & Oncology Associates of Northeastern PA
    • Kingston, Pennsylvania, United States, 18704
      • Medical Oncology Associates of Wyoming Valley, PC
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19114
      • Greater Philadelphia Cancer
    • Pittsburgh, Pennsylvania, United States, 15232
      • Univeristy of Pittsburgh Cancer Institute
    • Pottsville, Pennsylvania, United States, 17901
      • Pottsville Cancer Care
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Charleston, South Carolina, United States, 29403
      • Charleston Hematology Oncology PA
    • Greenville, South Carolina, United States, 29615
      • Cancer Centers of the Carolina
    • Hilton Head Island, South Carolina, United States, 29926
      • South Carolina Cancer Specialists
  • Tennessee
    • Chattanooga, Tennessee, United States, TN
      • Chattanooga Oncology & Hematology Assoc.
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Abilene, Texas, United States, 79606-5208
      • Texas Cancer Center-Abilene
    • Amarillo, Texas, United States, 79106
      • Texas Oncology, PA
    • Arlington, Texas, United States, 76014
      • Texas Cancer Center
    • Arlington, Texas, United States, 76017
      • Urology Associates of North Texas (UANT)
    • Austin, Texas, United States, 78731
      • Texas Oncology Cancer Center
    • Beaumont, Texas, United States, 77702-1449
      • MamieMcFaddin Ward Cancer Center
    • Dallas, Texas, United States, 75231-4400
      • Texas Oncology, P.A.
    • Dallas, Texas, United States, 75237
      • The Texas Cancer Center
    • Dallas, Texas, United States, 75230
      • Center for Oncology Research and Treatment, PA
    • Dallas, Texas, United States, 75230-2510
      • Texas Cancer Center ar Medical City
    • El Paso, Texas, United States, 79915
      • El Paso Cancer Treatment Center-East
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology, P.A.
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer & Blood Disorders
    • Garland, Texas, United States, 75042-5788
      • Texas Oncology, P.A.
    • Houston, Texas, United States, 77024
      • Texas Oncology, P.A.
    • Lewisville, Texas, United States, 75067
      • Lake Vista Cancer Center
    • Longview, Texas, United States, 75601
      • Texas Oncology, P.A.
    • Lubbock, Texas, United States, 79415
      • Southwest Cancer Treatment And Research Center
    • McAllen, Texas, United States, 78503
      • South Texas Cancer Center - McAllen
    • Mesquite, Texas, United States, 75150
      • Texas Cancer Center of Mesquite
    • Midland, Texas, United States, 79701-5946
      • Allison Cancer Center
    • New Braunfels, Texas, United States, 78131
      • Cancer Care Network of South Texas, HOAST
    • Odessa, Texas, United States, 79761
      • West Texas Cancer Center
    • Paris, Texas, United States, 75460-5004
      • Paris Regional Cancer Center
    • San Antonio, Texas, United States, 78229
      • South Texas Oncology and Hematology, PA
    • San Antonio, Texas, United States, 78233
      • InVisions Consultants LLC
    • Sherman, Texas, United States, 75090-0504
      • Texas Cancer Center- Sherman
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology Cancer Center-Sugar Land
    • Waco, Texas, United States, 76712
      • Texas Oncology Cancer Care and Research Center
    • Waco, Texas, United States, 76022
      • Texas Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Fairfax Northern Virginia Hematology Oncology, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Salem, Virginia, United States, 24153
      • Oncology & Hematology Associates Of Southwest Virginia, Inc.
  • Washington
    • Burien, Washington, United States, 98166
      • Highline Medical Oncology
    • Edmonds, Washington, United States, 98026
      • Puget Sound Cancer Centers
    • Seattle, Washington, United States, 98109
      • University of Washington
    • Seattle, Washington, United States, 98133
      • Puget Sound Cancer Centers
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C.
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital/North Star Lodge
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histopathologically or cytologically proven adenocarcinoma of the prostate
• Documented metastatic prostate adenocarcinoma
• Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2
• Adequate hematologic, renal and hepatic function
• Life expectancy >= 3 months

Exclusion Criteria:

• Prior chemotherapy, except estramustine
• Prior chemotherapy with docetaxel
• Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
• One or more contraindications to the use of corticosteroids
• History of cancer-related hypercalcemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Novacea
• Investigators: Study Chair: Howard I. Scher, MD, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center; Study Chair: Kim N. Chi, M.D., British Columbia Cancer Agency - Vancouver Centre; Study Chair: Ronald De-Wit, M.D., Erasmus University Medical Center (Netherlands)

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: December 14, 2005
• First Submitted That Met QC Criteria: January 5, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): November 6, 2007
• Last Update Submitted That Met QC Criteria: November 2, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Prostate Cancer; docetaxel; Taxotere; calcitriol; Androgen-independent Prostate Cancer (AIPC); DN-101
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Docetaxel; Calcitriol
• Other Study ID Numbers: 011-007