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Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Differentiated Thyroid Cancer

Intervention: Selumetinib (Drug); Placebo (Drug); Radioactive Iodine Therapy (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Alan Ho, M.D., PHD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.
Gabriella Mariani, M.D., PHD, Study Director, Affiliation: 11G34,Mereside,Alderley Park,Macclesfield, Cheshire, England

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: ClinicalTrialTransparency@astrazeneca.com

Summary

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Clinical Details

Official title: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients With Differentiated Thyroid Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Complete remission rate in overall study population

Secondary outcome:

Clinical remission rate in overall study population

Clinical remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS

Frequency of adverse events graded according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE)"

Selumetinib concentration profile over time

N-desmethyl selumetinib concentration profile over time

Selumetinib amide concentration profile over time

Complete remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS

Detailed description: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression Exclusion criteria: Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2

Locations and Contacts

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: ClinicalTrialTransparency@astrazeneca.com

Research Site, Marilia, Brazil; Withdrawn

Research Site, Porto Alegre, Brazil; Recruiting

Research Site, Ribeirão Preto, Brazil; Recruiting

Research Site, Rio de Janeiro, Brazil; Recruiting

Research Site, Sao Paulo, Brazil; Withdrawn

Research Site, São José do Rio Preto, Brazil; Recruiting

Research Site, São Paulo, Brazil; Recruiting

Research Site, Odense, Denmark; Recruiting

Research Site, Angers Cedex 01, France; Recruiting

Research Site, Bordeaux Cedex, France; Recruiting

Research Site, Caen Cedex 5, France; Recruiting

Research Site, Lyon, France; Recruiting

Research Site, Paris Cedex 10, France; Withdrawn

Research Site, Toulouse Cedex, France; Recruiting

Research Site, Villejuif Cedex, France; Recruiting

Research Site, Augsburg, Germany; Recruiting

Research Site, Essen, Germany; Recruiting

Research Site, Leipzig, Germany; Recruiting

Research Site, Marburg, Germany; Recruiting

Research Site, Würzburg, Germany; Recruiting

Research Site, Catania, Italy; Recruiting

Research Site, Milano, Italy; Recruiting

Research Site, Napoli, Italy; Recruiting

Research Site, Pisa, Italy; Recruiting

Research Site, Roma, Italy; Recruiting

Research Site, Siena, Italy; Withdrawn

Research Site, Gliwice, Poland; Recruiting

Research Site, Kielce, Poland; Recruiting

Research Site, Poznań, Poland; Recruiting

Research Site, Warszawa, Poland; Recruiting

Research Site, Zgierz, Poland; Recruiting

Research Site, Göteborg, Sweden; Recruiting

Research Site, Linköping, Sweden; Recruiting

Research Site, Lund, Sweden; Recruiting

Research Site, Stockholm, Sweden; Recruiting

Research Site, Birmingham, Alabama 35233, United States; Recruiting
Amy Warriner, Phone: 205-934-4112, Email: warriner@uab.edu
Susan Ferguson, Phone: 205-934-4112, Email: susanf@uab.edu

Research Site, Little Rock, Arkansas 72205, United States; Recruiting
Donald Bodenner, Phone: 501-944-5254, Email: BodennerDonald@uams.edu
Laura (Bekka) Wilkerson, Phone: 501-351-2232, Email: BWilkerson@uams.edu

Research Site, Los Angeles, California, United States; Recruiting
Wendy Sacks, Phone: 310-423-5140, Email: sacksw@cshs.org
Premere Knowles, Phone: 310-423-0721, Email: premere.session@cshs.org

Research Site, Torrance, California, United States; Recruiting
Andrew Gianoukakis, Phone: 310-222-8172, Email: agianoukakis@labiomed.org
Jolene Tan, Phone: 310-222-8172, Email: jolenetan@labiomed.org

Research Site, Aurora, Colorado, United States; Recruiting
Dr Bryan Haugen, Phone: 720-848-0678, Email: bryan.haugen@ucdenver.edu
Lauren Suppes, Phone: 720 848 0653, Email: lauren.suppes@ucdenver.edu

Research Site, Washington, District of Columbia, United States; Recruiting
Kenneth Burman, Phone: 202-877-8839, Email: kenneth.d.burman@medstar.net
Kaitlyn O'Keefe, Phone: 202-877-2749, Email: kaitlyn.okeefe@medstar.net

Research Site, Tampa, Florida, United States; Not yet recruiting
Dr Jeffrey Russell, Phone: 813-745-8118, Email: jeffrey.russel@moffitt.org

Research Site, Chicago, Illinois, United States; Withdrawn

Research Site, Boston, Massachusetts, United States; Recruiting
Lori Wirth, Phone: 617-726-8748, Email: Lori_Wirth@dfci.harvard.edu
Norka Snyder, Phone: 617 623 4448, Email: nsnyder@partners.org

Research Site, Boston, Massachusetts, United States; Recruiting
Lori Wirth, Phone: 617-632-5990, Email: Lori_Wirth@dfci.harvard.edu
Stacey Gundry, Phone: 617 582 8039

Research Site, New York, New York, United States; Recruiting
Alan Ho, Phone: 646-888-4235, Email: hoa@mskcc.org
Brynna Lipson, Phone: 646 888 4446, Email: lipsonb@mskcc.org

Research Site, New York, New York, United States; Recruiting
William Inabnet, Phone: 212-241-6918, Email: william.inabnet@mountsinai.org
Rachel Schrier, Phone: 212 241 1572, Email: rachel.schrier@mountsinai.org

Research Site, Durham, North Carolina, United States; Recruiting
Julie Sosa, Phone: 919-668-1767, Email: julie.sosa@duke.edu
Kristen Linney, Phone: 919 668 1767, Email: k.linney@duke.edu

Research Site, Cincinnati, Ohio, United States; Recruiting
David Steward, Phone: 513-475-8400, Email: STEWARDD@UCMAIL.UC.EDU
Jessica G. Keller, Phone: 513-558-1719, Email: jessica.keller@uc.edu

Research Site, Portland, Oregon, United States; Recruiting
Matthew Taylor, Phone: 503-494-8534, Email: taylmatt@ohsu.edu
Lindsay Chandler, Phone: 503 346 0792, Email: chandlli@ohsu.edu

Research Site, Philadelphia, Pennsylvania, United States; Recruiting
Marcia Brose, Phone: 215-615-6519, Email: brosem@mail.med.upenn.edu
Jillian Stanley

Research Site, Charleston, South Carolina, United States; Recruiting
Keisuke Shirai, Phone: 843-792-4271, Email: shirai@musc.edu
Kristina Woodruff, Phone: 843-792-6349, Email: woodrufk@musc.edu

Research Site, Nashville, Tennessee, United States; Recruiting
Leon Parks, Phone: 615-343-8332, Email: lee.parks@vanderbilt.edu
Wendy Cooper, Phone: 615 936 3064, Email: wendy.cooper@vanderbilt.edu

Additional Information

Starting date: August 2013
Last updated: August 4, 2015

Page last updated: August 23, 2015

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