Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
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ClinicalTrials.gov Identifier: NCT02015065 |
Recruitment Status :
Completed
First Posted : December 19, 2013
Results First Posted : July 23, 2019
Last Update Posted : March 30, 2020
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brigitte Widemann, M.D., National Cancer Institute (NCI)
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
GIST |
Intervention |
Drug: Vandetanib |
Enrollment | 9 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Due to lack of efficacy no participants were enrolled in Dose Level 150mg/m^2 Vandetanib Pediatric Arm/Group. |
Arm/Group Title | 200 mg Vandetanib Adult | 300 mg Vandetanib Adult | Dose Level 100mg/m^2 Vandetanib Pediatric |
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Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3. |
Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose |
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days. |
Period Title: Overall Study | |||
Started | 2 | 5 | 2 |
Completed | 1 | 3 | 1 |
Not Completed | 1 | 2 | 1 |
Reason Not Completed | |||
Death on study | 1 | 2 | 1 |
Baseline Characteristics
Arm/Group Title | 200 mg Vandetanib Adult | 300 mg Vandetanib Adult | Dose Level 100mg/m^2 Vandetanib Pediatric | Total | |
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Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3. |
Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose |
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days. | Total of all reporting groups | |
Overall Number of Baseline Participants | 2 | 5 | 2 | 9 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 5 participants | 2 participants | 9 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
2 100.0%
|
2 22.2%
|
|
Between 18 and 65 years |
2 100.0%
|
5 100.0%
|
0 0.0%
|
7 77.8%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
Number Analyzed | 2 participants | 5 participants | 2 participants | 9 participants | |
24.5 (3.0) | 34.3 (13.17) | 13.2 (2.12) | 27.42 (13.11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 5 participants | 2 participants | 9 participants | |
Female |
1 50.0%
|
4 80.0%
|
2 100.0%
|
7 77.8%
|
|
Male |
1 50.0%
|
1 20.0%
|
0 0.0%
|
2 22.2%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2 participants | 5 participants | 2 participants | 9 participants |
Not meeting definition for Hispanic or Latino |
2 100.0%
|
5 100.0%
|
1 50.0%
|
8 88.9%
|
|
Mexican, Puerto Rican, Cuban, Central or So. Amer. |
0 0.0%
|
0 0.0%
|
1 50.0%
|
1 11.1%
|
|
Black or African American |
1 50.0%
|
0 0.0%
|
0 0.0%
|
1 11.1%
|
|
White |
1 50.0%
|
5 100.0%
|
0 0.0%
|
6 66.7%
|
|
Asian |
0 0.0%
|
0 0.0%
|
1 50.0%
|
1 11.1%
|
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
|||||
United States | Number Analyzed | 2 participants | 5 participants | 2 participants | 9 participants |
2 100.0%
|
5 100.0%
|
2 100.0%
|
9 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Brigitte Widemann |
Organization: | National Cancer Institute |
Phone: | 240-760-6203 |
EMail: | widemanb@nih.gov |
Responsible Party: | Brigitte Widemann, M.D., National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT02015065 |
Other Study ID Numbers: |
130208 13-C-0208 |
First Submitted: | December 14, 2013 |
First Posted: | December 19, 2013 |
Results First Submitted: | February 28, 2019 |
Results First Posted: | July 23, 2019 |
Last Update Posted: | March 30, 2020 |