Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine

Conditions

• Recurrent Thyroid Gland Carcinoma
• Stage I Thyroid Gland Papillary Carcinoma
• Stage II Thyroid Gland Papillary Carcinoma
• Stage III Thyroid Gland Papillary Carcinoma
• Stage IV Thyroid Gland Papillary Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Selumetinib — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 31, 2007

Status verified

Dec 2016

Primary completion

Aug 31, 2016

Completion

Aug 31, 2016

Study Design

Enrollment

39 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]

Locations (5)

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