Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer (NCT NCT00519896)

NCT ID: NCT00519896

Last Updated: 2017-04-25

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Results posted on

2017-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Overall Study Protocol Violation	1
Overall Study Adverse Event	1

Baseline Characteristics

Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=35 Participants Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=33 Participants Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Overall Response Rate	11 Participants

SECONDARY outcome

Timeframe: On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years

Population: All patients that received at least one dose of sunitinib malate were included in the analysis.

Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=35 Participants Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Fatigue	4 participants
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Neutropenia	12 participants
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Hand/Foot syndrome	6 participants
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Diarrhea	6 participants
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Leukopenia	11 participants
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 Gastrointestional Hemorrhage	1 participants

SECONDARY outcome

Timeframe: At 30 days from the last dose of study treatment and then for 2 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=33 Participants Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease	12.8 months Interval 8.9 to The data collection time period ended before all patients experienced disease progression.

Adverse Events

Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=35 participants at risk Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
Gastrointestinal disorders Gastrointestional Bleed	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) n=35 participants at risk Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO
General disorders fatigue	25.7% 9/35 • Number of events 9 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Dehydration	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Anorexia	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Mucositis	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Diarrhea	25.7% 9/35 • Number of events 9 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Nausea/vomiting	8.6% 3/35 • Number of events 3 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Odynophagia	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Gastrointestinal disorders Gastrointestional Bleed	14.3% 5/35 • Number of events 5 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Skin and subcutaneous tissue disorders Hand/Foot Syndrome	25.7% 9/35 • Number of events 9 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders Hemoptysis	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Cardiac disorders Tachycardia	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Vascular disorders Hypertension	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders Leukopenia	31.4% 11/35 • Number of events 11 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders Neutropenia	34.3% 12/35 • Number of events 12 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders anemia	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders Thrombocytopenia	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Blood and lymphatic system disorders Epistaxis	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Metabolism and nutrition disorders Hypocalcemia	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Nervous system disorders Neuropathy	2.9% 1/35 • Number of events 1 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.
Infections and infestations Infection	5.7% 2/35 • Number of events 2 • adverse events were collected from the date of the first dose of sunitinib through 30 days following the last dose of sunitinib or up to 2 years.

Additional Information

Renato G Martins

University of Washington

Phone: 206-288-2048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place