Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine
Phase 2 Study of Selumetinib Hydrogen Sulfate in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements
8 other identifiers
interventional
39
2 countries
6
Brief Summary
This phase II trial is studying how well selumetinib works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2007
CompletedFirst Posted
Study publicly available on registry
November 19, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
January 30, 2017
CompletedJanuary 30, 2017
December 1, 2016
8.7 years
November 16, 2007
December 2, 2016
December 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.
Up to 2 years
Secondary Outcomes (3)
Median Progression-Free Survival (PFS)
Up to 2 years
Occurrence of Treatment Related Adverse Events
Up to 2 years
Overall Survival (OS)
Up to 2 years
Study Arms (1)
Arm I
EXPERIMENTALPatients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions
Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed papillary thyroid cancer or papillary thyroid cancer with follicular elements
- No longer amenable to radioactive iodine therapy or curative surgical resection
- Tumor is no longer iodine avid
- Tumor did not respond to the most recent radioactive iodine treatment
- Patient is ineligible for further radioactive iodine therapy due to medical contraindications (e.g., lung toxicity)
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- Evidence of disease progression (objective growth of existing tumors)
- New or enlarging measurable lesions within the past 12 months
- If the most recent imaging study is older than 12 months, patients will still be eligible if objectively measurable disease progression is associated with clinical symptoms
- Archival tumor tissue available for mutational analysis
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- WBC ≥ 3,000/µL
- ANC ≥ 1,500/µL
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Hayes DN, Lucas AS, Tanvetyanon T, Krzyzanowska MK, Chung CH, Murphy BA, Gilbert J, Mehra R, Moore DT, Sheikh A, Hoskins J, Hayward MC, Zhao N, O'Connor W, Weck KE, Cohen RB, Cohen EE. Phase II efficacy and pharmacogenomic study of Selumetinib (AZD6244; ARRY-142886) in iodine-131 refractory papillary thyroid carcinoma with or without follicular elements. Clin Cancer Res. 2012 Apr 1;18(7):2056-65. doi: 10.1158/1078-0432.CCR-11-0563. Epub 2012 Jan 12.
PMID: 22241789BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Actuarial OS cannot be estimated due to long survival times in this disease.
Results Point of Contact
- Title
- Dr. David Neil Hayes
- Organization
- UNC Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David Neil Hayes
UNC Lineberger Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2007
First Posted
November 19, 2007
Study Start
December 1, 2007
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
January 30, 2017
Results First Posted
January 30, 2017
Record last verified: 2016-12